Skip to content

EXERCISING TOGETHER for Couples Coping With Cancer

EXERCISING TOGETHER © for Couples Coping With Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03630354
Enrollment
496
Registered
2018-08-14
Start date
2019-01-18
Completion date
2024-03-31
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma, Colorectal Carcinoma, Malignant Solid Neoplasm, Prostate Carcinoma, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8

Brief summary

The Exercising Together trial is a single-blind, parallel group, randomized controlled trial comparing 3 arms: Arm 1 (experimental): Exercising Together where couples perform partnered exercise in a supervised, group setting versus two comparator conditions where survivors and partners perform exercise routines separately in either a supervised group setting (Arm 2) or unsupervised at home (Arm 3). All three arms will train for a 6-month period and then be followed 6 months later. Data will be collected at baseline, 3, 6 and 12 months.

Detailed description

PRIMARY OBJECTIVES: I. Determine the efficacy of Exercising Together on relationship quality (intimacy, communication and incongruence) in couples coping with prostate cancer (PC), breast cancer (BC), or colorectal cancer (CRC). II. Determine the efficacy of Exercising Together on the physical health (body composition, lipids, insulin resistance, blood pressure, inflammation, and physical function) and mental health (anxiety, depressive symptoms, fear of recurrence) of both the survivor and spouse/partner. III. Determine how long individual and couple-level benefits from Exercising Together last. EXPLORATORY OBJECTIVE: I. Identify the types of couples that benefit most from Exercising Together. OUTLINE: Study is a 3-group, 12-month (6 months of exercise training + 6-months follow-up) randomized trial. ARM I: Exercising Together Program: Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting. ARM II: Exercising Together Program: Survivors and spouses/partners perform exercise routines separately in a supervised group setting ARM III: Survivors and partners undergo 2 training sessions over 1 hour with an exercise trainer and then perform exercise routines over 1 hour 2 days per week separately unsupervised at home or a facility following an instructional digital video disc (DVD). The basic training program for all three study arms is a functional strength training program. Participants will use free weights (weighted vest, dumbbells, elastic bands) while performing lower body (chair rises, squats, lunges, stepups) and upper body (1-arm row, bench press, push-ups, triceps extension, bicep curls, shoulder raise) resistance exercise. Volume of resistance exercise, determined by intensity (weight, tailored to each individual) and duration (number of repetitions and sets), is gradually increased from low weight and high repetitions to more weight and fewer repetitions over the training period.

Interventions

BEHAVIORALExercise Intervention (supervised)

Complete supervised exercise

BEHAVIORALExercise Intervention (unsupervised)

Complete unsupervised exercise

OTHERInformational Intervention

Receive instructional DVD

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Oregon Health and Science University
CollaboratorOTHER
OHSU Knight Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* SURVIVORS ONLY: * Histologically confirmed PC, BC or CRC without evidence of metastatic disease (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician) * Three years or less from diagnosis date, by month and year, at time of enrollment (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician) * Completed treatment (e.g., surgery, radiation and/or chemotherapy) \>= 6 weeks prior to enrollment. Concurrent adjuvant hormone therapy is permitted and must have been initiated \>= 6 weeks prior to enrollment. For prostate cancer, androgen deprivation therapy (ADT) may constitute primary treatment and must have been initiated \>= 6 weeks prior to enrollment. For breast cancer, hormone therapy may constitute primary treatment and must have been initiated \>= 6 weeks prior to enrollment. (confirmed by self-report on Health History Questionnaire. In the case a participant isn't able to confirm this criterion, a letter will be sent to his or her physician) * Co-residing with an intimate partner or spouse who is willing to participate (confirmed by self-report on Health History Questionnaire) * SURVIVORS AND SPOUSES/PARTNERS: * Underactive (\< 2 strength training sessions per week, lasting 30 minutes or more per session, at a moderate intensity in the last month) (confirmed by self-report on Health History Questionnaire or by discretion of the principal investigator)

Exclusion criteria

* SURVIVORS AND SPOUSES/PARTNERS * Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the principal investigator, Dr. Kerri Winters-Stone * A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate (use of an assistive device permitted), inability to stand for 3 minutes, severe hearing or vision problem. (For Survivor: Confirmed by physician clearance; For Spouse/Partner: must answer 'No' to American College of Sports Medicine pre-participation screening questions. If spouse/partner answers 'Yes' to either question they will be considered eligible upon physician clearance. Physician clearance may also be requested at the discretion of the principal investigator. For either: absence of pregnancy in persons who could possibly be pregnant but have not declared a pregnancy at screening, will be further screened with a pregnancy test administered at each testing visit.) * Knowingly unable to attend \> 75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled. (Confirmed by documentation in the Case Report Form titled CRF - Participant Contact Info\_Exercising Together) * Not fluent in English and therefore incapable of answering survey questions, participating in class, following directions during performance testing, and providing informed consent when English is the language used. (Confirmed by documentation in the Case Report Form titled CRF - Participant Contact Info\_Exercising Together or the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone.)

Design outcomes

Primary

MeasureTime frameDescription
Dyadic Coping - Active EngagementBaseline, 3, 6 and 12 monthsMeasured by the Active Engagement subscale from the Relationship Focused Coping Scale. The subscale assesses the degree with which couples practice active engagement by responding to five items on a Likert scale from 1 (never) to 5 (very often). Scores range from 5 to 25, with higher scores indicating more active engagement. Reported values reflect the estimated slope over 6-months.
Dyadic Coping - Protective BufferingBaseline, 3, 6, and 12 monthsMeasured by the Protective Buffering Subscale from the Relationship Focused Coping Scale. Assesses the degree with which couples practice protective buffering by responding to six items using a Likert scale of 1 (never) to 5 (very often). Scores range from 6 to 30 with higher scores indicating more protective buffering. Reported values reflect the estimated slope over 6-months.
Emotional IntimacyBaseline, 3, 6 and 12 monthsMeasured by the 7-item Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering 7 questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree). Scores range from 0-21 with higher scores indicating better dyadic adjustment. Reported values reflect the estimated slope over 6-months.
Physical Intimacy - Engagement in SexBaseline, 3, 6 and 12 monthsMeasured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in sexual behaviors answering two questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 2 to 8 with higher scores indicating higher physical intimacy.
Physical Intimacy - Engagement in Affectionate BehaviorsBaseline, 3, 6, and 12-monthsMeasured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in affectionate behaviors answering four questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 4 to 16 with higher scores indicating higher physical intimacy.
Concealment of SymptomsBaseline, 3, 6 and 12 monthsMeasured by the Emotional-Intimacy Disruptive Behavior Scale. Patients report the extent to which they engage in 8 behaviors using a scale from 1 (rarely or none of the time) to 4 (most or all of the time). Scores range from 8-32 where higher scores indicate more concealment Reported values reflect the estimated slope over 6-months.
Pain Incongruence - Pain IntensityBaseline, 3, 6 and 12 monthsMeasured by the degree of agreement (change or difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate no pain and high values represent pain as bad as you can imagine. Reported values reflect the estimated slope over 6-months.
Pain Incongruence - Pain InterferenceBaseline, 3, 6 and 12 monthsMeasured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate no pain and high values represent pain as bad as you can imagine. Reported values reflect the estimated slope over 6-months.
Fatigue IncongruenceBaseline, 3, 6 and 12 monthsMeasured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's fatigue in the past 7 days using the Functional Assessment in Chronic Illness Therapy (FACIT) fatigue questionnaire. This instrument has 13 items, and possible scores from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue. Reported values reflect the estimated slope over 6-months.
Perceived Physical Function IncongruenceBaseline, 3, 6 and 12 monthsMeasured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's physical function in the past 4 weeks using the perceived physical function subscale of the SF-36 medical outcomes survey. Possible scores range from 0-100. Low scores indicate a high degree of limitation in performing physical activities, whereas high scores represent no limitations in performing physical activities due to health. Reported values reflect the estimated slope over 6-months.

Secondary

MeasureTime frameDescription
Quality of Life (QOL): QLQ-C30 - Physical FunctioningBaseline, 3, 6 and 12 monthsMeasures QOL in cancer patients including subscales of physical functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Quality of Life (QOL): QLQ-C30 - Emotional FunctioningBaseline, 3, 6, 12 monthsMeasures QOL in cancer patients including subscales of emotional functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.
Quality of Life (QOL): SF-36 Physical Function SubscaleBaseline, 3, 6 and 12 monthsThe SF-36 measures quality of life using 8 subscales: perceived physical function, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. All subscales have possible scores from 0-100, with items from each subscale averaged together. Low scores indicate worse physical functioning, while higher scores indicate better physical functioning.
Body Composition - Bone-free Lean MassBaseline, 3, 6 and 12 monthsMeasured by bone-free lean (kg) for the whole body determined from a whole body dual energy x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Anxiety: PROMIS Anxiety Short FormBaseline, 3, 6 and 12 monthsMeasured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form 8a, using T score, standardized to mean = 50, SD = 10. Possible range for this short form is 37.1-83.1. Higher T scores reflect higher anxiety. Reported values reflect the estimated slope over 6-months.
Fear of RecurrenceBaseline, 3, 6 and 12 monthsMeasured by the Fear of Recurrence scale to assess the amount of concern survivors have about their cancer returning in the future. Participants respond to 22 questions ranging from 1 (strongly agree) to 5 (strongly disagree). The possible range is 22-110. Higher scores reflect higher fear. Reported values reflect the estimated slope over 6-months.
Depressive Symptoms: CES-DBaseline, 3, 6 and 12 monthsMeasured by the Center for Epidemiological Studies-Depression (CES-D) scale to determine the degree of depressive symptoms. Scores range from 0-60, with higher scores indicating more symptoms that occur at higher frequencies.
Body Composition - Fat MassBaseline, 3, 6, and 12 monthsMeasured by fat mas (kg) for the whole body determined from a whole body dual x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.
Cardiovascular Health: Serum CholesterolBaseline, 3, 6 and 12 monthsMeasured by serum fasting total cholesterol.
Cardiovascular Health: Serum TriglyceridesBaseline, 3, 6, and 12 monthsMeasured by serum triglycerides.
Cardiovascular Health: Insulin ResistanceBaseline, 3, 6 and 12 monthsMeasured by Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) - used to assess insulin sensitivity and predict the risk of type 2 diabetes and other metabolic disorders. Calculated as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant, 405. Scores generally range from 0.5 to 2.5, with lower scores indicating better insulin sensitivity and higher scores suggesting higher insulin resistance. A HOMA-IR score of 1.0 or less is considered optimal, while scores above 2.9 may indicate significant insulin resistance. Reported values reflect the estimated slope over 6-months. (Glucose mg/dL \* insulin uIU/ml) / 405
Cardiovascular Health: Resting Systolic Blood PressureBaseline, 3, 6 and 12 monthsMeasured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Cardiovascular Health: Resting Diastolic Blood PressureBaseline, 3, 6, 12 monthsMeasured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).
Inflammation-hsCRPBaseline, 3, 6 and 12 monthsMeasured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.
Inflammation-TNF AlphaBaseline, 3, 6 and 12 monthsMeasured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.
Objective Physical FunctionBaseline, 3, 6 and 12 monthsMeasured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

Countries

United States

Participant flow

Recruitment details

Community-dwelling couples were recruited between January 2019 and October 2022. The first couple was enrolled on January 18, 2019 and the last was couple was enrolled on October 26, 2022.

Pre-assignment details

Of 269 consented couples, 248 couples (496 individuals: 248 survivors + 248 partners) met inclusion criteria and were randomized to an intervention group.

Participants by arm

ArmCount
Arm I (Supervised Exercise Together)
Couples perform partnered exercise over 1 hour, 2 days per week in a supervised, group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies
164
Arm II (Supervised Exercise Separately)
Survivors and partners perform exercise routines over 1 hour, 2 days per week separately in a supervised group setting remotely for 6 months. Exercise Intervention: Complete supervised exercise Questionnaire Administration: Ancillary studies
170
Arm III (Unsupervised Exercise Separately)
Survivors and partners undergo 2 training sessions remotely over 1 hour with an exercise trainer and then perform exercise routines over 1 hour, 2 days per week unsupervised at home or a facility following an instructional DVD. Exercise Intervention: Complete unsupervised exercise Informational Intervention: Receive instructional DVD Questionnaire Administration: Ancillary studies
162
Total496

Baseline characteristics

CharacteristicArm I (Supervised Exercise Together)Arm II (Supervised Exercise Separately)Arm III (Unsupervised Exercise Separately)Total
Age, Continuous64.8 years
STANDARD_DEVIATION 9.46
62.7 years
STANDARD_DEVIATION 10.7
62.6 years
STANDARD_DEVIATION 65.5
63.4 years
STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants1 Participants3 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
78 Participants82 Participants78 Participants238 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants2 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants5 Participants9 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
2 Participants4 Participants3 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants3 Participants4 Participants
Race (NIH/OMB)
White
77 Participants75 Participants72 Participants223 Participants
Region of Enrollment
United States
82 Participants85 Participants81 Participants248 Participants
Sex: Female, Male
Female
41 Participants45 Participants46 Participants133 Participants
Sex: Female, Male
Male
41 Participants42 Participants35 Participants115 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1640 / 1700 / 162
other
Total, other adverse events
9 / 1646 / 1703 / 162
serious
Total, serious adverse events
4 / 1642 / 1701 / 162

Outcome results

Primary

Concealment of Symptoms

Measured by the Emotional-Intimacy Disruptive Behavior Scale. Patients report the extent to which they engage in 8 behaviors using a scale from 1 (rarely or none of the time) to 4 (most or all of the time). Scores range from 8-32 where higher scores indicate more concealment Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Concealment of SymptomsSurvivor: 6mo-12mo-.23 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Concealment of SymptomsSurvivor: Baseline-6mo-.24 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Concealment of SymptomsPartner: 6mo-12mo.63 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Concealment of SymptomsPartner: Baseline-6mo-.33 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Concealment of SymptomsSurvivor: Baseline-6mo.07 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Concealment of SymptomsPartner: 6mo-12mo-.23 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Concealment of SymptomsPartner: Baseline-6mo-.44 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Concealment of SymptomsSurvivor: 6mo-12mo-.18 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Concealment of SymptomsPartner: 6mo-12mo-.11 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Concealment of SymptomsPartner: Baseline-6mo-.70 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Concealment of SymptomsSurvivor: 6mo-12mo.53 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Concealment of SymptomsSurvivor: Baseline-6mo-.82 Score on a scale per 6 months
Primary

Dyadic Coping - Active Engagement

Measured by the Active Engagement subscale from the Relationship Focused Coping Scale. The subscale assesses the degree with which couples practice active engagement by responding to five items on a Likert scale from 1 (never) to 5 (very often). Scores range from 5 to 25, with higher scores indicating more active engagement. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Dyadic Coping - Active EngagementSurvivor: Baseline-6mo-0.45 score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Active EngagementSurvivor: 6mo-12mo-0.35 score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Active EngagementPartner: 6mo-12mo-0.52 score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Active EngagementPartner: Baseline-6mo0.05 score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Active EngagementSurvivor: 6mo-12mo-0.61 score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Active EngagementSurvivor: Baseline-6mo0.81 score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Active EngagementPartner: Baseline-6mo-0.08 score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Active EngagementPartner: 6mo-12mo-0.14 score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Active EngagementPartner: 6mo-12mo-0.35 score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Active EngagementPartner: Baseline-6mo-0.91 score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Active EngagementSurvivor: Baseline-6mo0.07 score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Active EngagementSurvivor: 6mo-12mo-0.08 score on a scale per 6 months
Primary

Dyadic Coping - Protective Buffering

Measured by the Protective Buffering Subscale from the Relationship Focused Coping Scale. Assesses the degree with which couples practice protective buffering by responding to six items using a Likert scale of 1 (never) to 5 (very often). Scores range from 6 to 30 with higher scores indicating more protective buffering. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6, and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Dyadic Coping - Protective BufferingPartner: 6mo-12mo-0.04 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Protective BufferingSurvivor: 6mo-12mo-0.21 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Protective BufferingPartner: Baseline-6mo0.36 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Dyadic Coping - Protective BufferingSurvivor: Baseline-6mo-0.48 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Protective BufferingSurvivor: Baseline-6mo-0.18 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Protective BufferingPartner: Baseline-6mo-0.09 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Protective BufferingSurvivor: 6mo-12mo-0.46 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Dyadic Coping - Protective BufferingPartner: 6mo-12mo-0.20 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Protective BufferingSurvivor: 6mo-12mo-0.57 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Protective BufferingPartner: 6mo-12mo-0.27 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Protective BufferingSurvivor: Baseline-6mo-0.13 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Dyadic Coping - Protective BufferingPartner: Baseline-6mo0.36 Score on a scale per 6 months
Primary

Emotional Intimacy

Measured by the 7-item Dyadic Adjustment Scale (DAS) to assess each partner's satisfaction with their relationship by answering 7 questions on a 6-point scale ranging from 1(always agree) to 6 (always disagree). Scores range from 0-21 with higher scores indicating better dyadic adjustment. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Emotional IntimacyPartner: Baseline-6mo.98 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Emotional IntimacySurvivor: Baseline-6mo3.37 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Emotional IntimacyPartner: 6mo-12mo-2.63 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Emotional IntimacySurvivor: 6mo-12mo-2.87 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Emotional IntimacyPartner: Baseline-6mo1.90 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Emotional IntimacySurvivor: 6mo-12mo-2.30 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Emotional IntimacySurvivor: Baseline-6mo2.61 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Emotional IntimacyPartner: 6mo-12mo-.43 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Emotional IntimacyPartner: 6mo-12mo1.96 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Emotional IntimacySurvivor: Baseline-6mo2.97 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Emotional IntimacySurvivor: 6mo-12mo-1.33 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Emotional IntimacyPartner: Baseline-6mo-.99 Score on a scale per 6 months
Primary

Fatigue Incongruence

Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's fatigue in the past 7 days using the Functional Assessment in Chronic Illness Therapy (FACIT) fatigue questionnaire. This instrument has 13 items, and possible scores from 0 to 52. Low values indicate no fatigue, while high values indicate high fatigue. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Fatigue IncongruenceBaseline-6mo1.02 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Fatigue Incongruence6mo-12mo-1.20 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Fatigue IncongruenceBaseline-6mo-1.24 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Fatigue Incongruence6mo-12mo-.03 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Fatigue IncongruenceBaseline-6mo-.41 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Fatigue Incongruence6mo-12mo-.67 Score on a scale per 6 months
Primary

Pain Incongruence - Pain Intensity

Measured by the degree of agreement (change or difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate no pain and high values represent pain as bad as you can imagine. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Pain Incongruence - Pain IntensityBaseline-6mo.17 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Pain Incongruence - Pain Intensity6mo-12mo-.08 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Pain Incongruence - Pain IntensityBaseline-6mo.08 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Pain Incongruence - Pain Intensity6mo-12mo.16 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Pain Incongruence - Pain IntensityBaseline-6mo.16 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Pain Incongruence - Pain Intensity6mo-12mo.16 Score on a scale per 6 months
Primary

Pain Incongruence - Pain Interference

Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's pain using the Brief Pain Inventory (BPI). This instrument has 2 subscales, pain intensity and pain interference. Values from items within each subscale are averaged together to yield scores 0-10. Low values indicate no pain and high values represent pain as bad as you can imagine. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Pain Incongruence - Pain InterferenceBaseline-6mo-.38 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Pain Incongruence - Pain Interference6mo-12mo.27 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Pain Incongruence - Pain Interference6mo-12mo-.09 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Pain Incongruence - Pain InterferenceBaseline-6mo.01 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Pain Incongruence - Pain InterferenceBaseline-6mo-.05 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Pain Incongruence - Pain Interference6mo-12mo.16 Score on a scale per 6 months
Primary

Perceived Physical Function Incongruence

Measured by the degree of agreement (difference) between the survivor and partner ratings of the survivor's physical function in the past 4 weeks using the perceived physical function subscale of the SF-36 medical outcomes survey. Possible scores range from 0-100. Low scores indicate a high degree of limitation in performing physical activities, whereas high scores represent no limitations in performing physical activities due to health. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Perceived Physical Function IncongruenceBaseline-6mo.41 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Perceived Physical Function Incongruence6mo-12mo1.33 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Perceived Physical Function Incongruence6mo-12mo.62 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Perceived Physical Function IncongruenceBaseline-6mo-.66 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Perceived Physical Function IncongruenceBaseline-6mo-.83 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Perceived Physical Function Incongruence6mo-12mo1.29 Score on a scale per 6 months
Primary

Physical Intimacy - Engagement in Affectionate Behaviors

Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in affectionate behaviors answering four questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 4 to 16 with higher scores indicating higher physical intimacy.

Time frame: Baseline, 3, 6, and 12-months

Population: This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: Baseline-6mo0.30 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: 6mo-12mo-0.04 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: Baseline-6mo0.37 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: 6mo-12mo-0.37 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: 6mo-12mo0.02 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: Baseline-6mo0.08 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: Baseline-6mo0.29 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: 6mo-12mo-0.18 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: 6mo-12mo-0.15 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsPartner: Baseline-6mo0.23 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: Baseline-6mo0.19 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in Affectionate BehaviorsSurvivor: 6mo-12mo0.15 Score on a scale per 6 months
Primary

Physical Intimacy - Engagement in Sex

Measured by the Physical Intimacy Behavior scale which asks participants the frequency that they engage in sexual behaviors answering two questions on a scale from 1 (none of the time) to 4 (most or all of the time). Scores range from 2 to 8 with higher scores indicating higher physical intimacy.

Time frame: Baseline, 3, 6 and 12 months

Population: This measure had a significant amount of missing data (due to the sensitivity of the questions) so the total sample size is reduced.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in SexPartner: Baseline-6mo0.10 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in SexPartner: 6mo-12mo-0.12 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in SexSurvivor: Baseline-6mo0.08 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Physical Intimacy - Engagement in SexSurvivor: 6mo-12mo-0.02 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in SexPartner: Baseline-6mo0.16 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in SexSurvivor: 6mo-12mo0.19 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in SexPartner: 6mo-12mo-0.23 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Physical Intimacy - Engagement in SexSurvivor: Baseline-6mo-0.04 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in SexPartner: 6mo-12mo0.03 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in SexSurvivor: Baseline-6mo-0.07 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in SexSurvivor: 6mo-12mo-0.02 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Physical Intimacy - Engagement in SexPartner: Baseline-6mo-0.08 Score on a scale per 6 months
Secondary

Anxiety: PROMIS Anxiety Short Form

Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety short form 8a, using T score, standardized to mean = 50, SD = 10. Possible range for this short form is 37.1-83.1. Higher T scores reflect higher anxiety. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Anxiety: PROMIS Anxiety Short FormSurvivor: Baseline-6mo-1.93 T score on a scale per 6 months
Arm I (Supervised Exercise Together)Anxiety: PROMIS Anxiety Short FormSurvivor: 6mo-12mo-0.30 T score on a scale per 6 months
Arm I (Supervised Exercise Together)Anxiety: PROMIS Anxiety Short FormPartner: Baseline-6mo-1.71 T score on a scale per 6 months
Arm I (Supervised Exercise Together)Anxiety: PROMIS Anxiety Short FormPartner: 6mo-12mo1.17 T score on a scale per 6 months
Arm II (Supervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormPartner: 6mo-12mo-0.16 T score on a scale per 6 months
Arm II (Supervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormSurvivor: Baseline-6mo-2.23 T score on a scale per 6 months
Arm II (Supervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormPartner: Baseline-6mo-0.94 T score on a scale per 6 months
Arm II (Supervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormSurvivor: 6mo-12mo0.42 T score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormPartner: 6mo-12mo-1.25 T score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormSurvivor: 6mo-12mo-0.23 T score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormPartner: Baseline-6mo-1.40 T score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Anxiety: PROMIS Anxiety Short FormSurvivor: Baseline-6mo-1.18 T score on a scale per 6 months
Secondary

Body Composition - Bone-free Lean Mass

Measured by bone-free lean (kg) for the whole body determined from a whole body dual energy x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Body Composition - Bone-free Lean MassPartner: 6mo-12mo-1.43 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Bone-free Lean MassSurvivor: Baseline-6mo3.38 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Bone-free Lean MassPartner: Baseline-6mo3.20 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Bone-free Lean MassSurvivor: 6mo-12mo-0.89 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Bone-free Lean MassPartner: Baseline-6mo3.32 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Bone-free Lean MassPartner: 6mo-12mo-1.03 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Bone-free Lean MassSurvivor: 6mo-12mo-0.60 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Bone-free Lean MassSurvivor: Baseline-6mo3.19 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Bone-free Lean MassPartner: 6mo-12mo-1.05 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Bone-free Lean MassSurvivor: 6mo-12mo-1.04 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Bone-free Lean MassPartner: Baseline-6mo3.17 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Bone-free Lean MassSurvivor: Baseline-6mo3.19 kg per 6 months
Secondary

Body Composition - Fat Mass

Measured by fat mas (kg) for the whole body determined from a whole body dual x-ray absorptiometry (DXA) (Hologic-QDR Discovery Wi; APEX software, v.4.02) scan.

Time frame: Baseline, 3, 6, and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Body Composition - Fat MassSurvivor: Baseline-6mo-3.32 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Fat MassSurvivor: 6mo-12mo1.38 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Fat MassPartner: Baseline-6mo-3.63 kg per 6 months
Arm I (Supervised Exercise Together)Body Composition - Fat MassPartner: 6mo-12mo0.22 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Fat MassPartner: 6mo-12mo0.87 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Fat MassSurvivor: Baseline-6mo-3.50 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Fat MassPartner: Baseline-6mo-3.36 kg per 6 months
Arm II (Supervised Exercise Separately)Body Composition - Fat MassSurvivor: 6mo-12mo1.05 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Fat MassPartner: 6mo-12mo0.25 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Fat MassSurvivor: 6mo-12mo0.53 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Fat MassPartner: Baseline-6mo-3.16 kg per 6 months
Arm III (Unsupervised Exercise Separately)Body Composition - Fat MassSurvivor: Baseline-6mo-2.77 kg per 6 months
Secondary

Cardiovascular Health: Insulin Resistance

Measured by Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) - used to assess insulin sensitivity and predict the risk of type 2 diabetes and other metabolic disorders. Calculated as the product of glucose and insulin, obtained from a fasting blood sample, divided by a constant, 405. Scores generally range from 0.5 to 2.5, with lower scores indicating better insulin sensitivity and higher scores suggesting higher insulin resistance. A HOMA-IR score of 1.0 or less is considered optimal, while scores above 2.9 may indicate significant insulin resistance. Reported values reflect the estimated slope over 6-months. (Glucose mg/dL \* insulin uIU/ml) / 405

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Cardiovascular Health: Insulin ResistanceSurvivor: Baseline-6mo-0.06 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Insulin ResistancePartner: 6mo-12mo-0.01 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Insulin ResistanceSurvivor: 6mo-12mo-0.05 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Insulin ResistancePartner: Baseline-6mo0.01 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Insulin ResistancePartner: Baseline-6mo-0.13 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Insulin ResistanceSurvivor: 6mo-12mo0.01 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Insulin ResistancePartner: 6mo-12mo0.13 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Insulin ResistanceSurvivor: Baseline-6mo-0.02 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Insulin ResistancePartner: 6mo-12mo-0.08 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Insulin ResistanceSurvivor: 6mo-12mo-0.03 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Insulin ResistancePartner: Baseline-6mo0.03 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Insulin ResistanceSurvivor: Baseline-6mo-0.01 Score on a scale per 6 months
Secondary

Cardiovascular Health: Resting Diastolic Blood Pressure

Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).

Time frame: Baseline, 3, 6, 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: Baseline-6mo-2.07 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Diastolic Blood PressurePartner: Baseline-6mo-3.26 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: 6mo-12mo1.42 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Diastolic Blood PressurePartner: 6mo-12mo-0.58 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: Baseline-6mo-4.10 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressurePartner: 6mo-12mo-1.30 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressurePartner: Baseline-6mo-4.93 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: 6mo-12mo1.14 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressurePartner: 6mo-12mo-2.26 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressurePartner: Baseline-6mo-2.50 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: 6mo-12mo1.48 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Diastolic Blood PressureSurvivor: Baseline-6mo-2.34 mmHg per 6 months
Secondary

Cardiovascular Health: Resting Systolic Blood Pressure

Measured by the average of three consecutive resting blood pressure measurements (systolic and diastolic pressures).

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: Baseline-6mo-4.91 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: 6mo-12mo0.83 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Systolic Blood PressurePartner: Baseline-6mo-5.92 mmHg per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Resting Systolic Blood PressurePartner: 6mo-12mo-0.41 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressurePartner: 6mo-12mo-7.02 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: Baseline-6mo-5.50 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressurePartner: Baseline-6mo-7.58 mmHg per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: 6mo-12mo3.46 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressurePartner: 6mo-12mo-1.56 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: 6mo-12mo2.38 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressurePartner: Baseline-6mo-7.93 mmHg per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Resting Systolic Blood PressureSurvivor: Baseline-6mo-3.34 mmHg per 6 months
Secondary

Cardiovascular Health: Serum Cholesterol

Measured by serum fasting total cholesterol.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum CholesterolSurvivor: Baseline-6mo-4.23 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum CholesterolSurvivor: 6mo-12mo3.77 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum CholesterolPartner: Baseline-6mo-2.89 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum CholesterolPartner: 6mo-12mo-1.30 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum CholesterolPartner: 6mo-12mo-3.11 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum CholesterolSurvivor: Baseline-6mo2.74 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum CholesterolPartner: Baseline-6mo-2.18 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum CholesterolSurvivor: 6mo-12mo-0.71 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum CholesterolPartner: 6mo-12mo0.85 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum CholesterolSurvivor: 6mo-12mo2.68 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum CholesterolPartner: Baseline-6mo-2.91 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum CholesterolSurvivor: Baseline-6mo-6.45 mg/dL per 6 months
Secondary

Cardiovascular Health: Serum Triglycerides

Measured by serum triglycerides.

Time frame: Baseline, 3, 6, and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum TriglyceridesPartner: Baseline-6mo-4.53 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum TriglyceridesSurvivor: 6mo-12mo4.79 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum TriglyceridesPartner: 6mo-12mo-8.44 mg/dL per 6 months
Arm I (Supervised Exercise Together)Cardiovascular Health: Serum TriglyceridesSurvivor: Baseline-6mo-9.86 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesSurvivor: 6mo-12mo-0.15 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesPartner: 6mo-12mo-15.28 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesSurvivor: Baseline-6mo7.00 mg/dL per 6 months
Arm II (Supervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesPartner: Baseline-6mo11.13 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesSurvivor: Baseline-6mo-9.76 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesPartner: 6mo-12mo16.41 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesPartner: Baseline-6mo2.64 mg/dL per 6 months
Arm III (Unsupervised Exercise Separately)Cardiovascular Health: Serum TriglyceridesSurvivor: 6mo-12mo12.02 mg/dL per 6 months
Secondary

Depressive Symptoms: CES-D

Measured by the Center for Epidemiological Studies-Depression (CES-D) scale to determine the degree of depressive symptoms. Scores range from 0-60, with higher scores indicating more symptoms that occur at higher frequencies.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Depressive Symptoms: CES-DSurvivor: Baseline-6mo-1.50 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Depressive Symptoms: CES-DSurvivor: 6mo-12mo-0.10 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Depressive Symptoms: CES-DPartner: Baseline-6mo-1.41 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Depressive Symptoms: CES-DPartner: 6mo-12mo1.07 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Depressive Symptoms: CES-DPartner: 6mo-12mo-0.29 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Depressive Symptoms: CES-DSurvivor: Baseline-6mo-0.72 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Depressive Symptoms: CES-DPartner: Baseline-6mo-1.73 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Depressive Symptoms: CES-DSurvivor: 6mo-12mo0.26 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Depressive Symptoms: CES-DPartner: 6mo-12mo0.83 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Depressive Symptoms: CES-DSurvivor: 6mo-12mo-0.21 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Depressive Symptoms: CES-DPartner: Baseline-6mo-1.76 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Depressive Symptoms: CES-DSurvivor: Baseline-6mo-1.10 Score on a scale per 6 months
Secondary

Fear of Recurrence

Measured by the Fear of Recurrence scale to assess the amount of concern survivors have about their cancer returning in the future. Participants respond to 22 questions ranging from 1 (strongly agree) to 5 (strongly disagree). The possible range is 22-110. Higher scores reflect higher fear. Reported values reflect the estimated slope over 6-months.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Fear of RecurrenceSurvivor: Baseline-6mo-2.61 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Fear of RecurrenceSurvivor: 6mo-12mo-1.63 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Fear of RecurrenceSurvivor: Baseline-6mo-2.48 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Fear of RecurrenceSurvivor: 6mo-12mo-1.72 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Fear of RecurrenceSurvivor: Baseline-6mo-3.72 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Fear of RecurrenceSurvivor: 6mo-12mo-0.31 Score on a scale per 6 months
Secondary

Inflammation-hsCRP

Measured by serum levels of high sensitivity C-reactive protein (hsCRP) obtained from a fasting blood sample.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Inflammation-hsCRPSurvivor: Baseline-6mo-0.11 mg/L per 6 months
Arm I (Supervised Exercise Together)Inflammation-hsCRPSurvivor: 6mo-12mo-0.12 mg/L per 6 months
Arm I (Supervised Exercise Together)Inflammation-hsCRPPartner: Baseline-6mo0.01 mg/L per 6 months
Arm I (Supervised Exercise Together)Inflammation-hsCRPPartner: 6mo-12mo-0.12 mg/L per 6 months
Arm II (Supervised Exercise Separately)Inflammation-hsCRPPartner: 6mo-12mo-0.13 mg/L per 6 months
Arm II (Supervised Exercise Separately)Inflammation-hsCRPSurvivor: Baseline-6mo0.09 mg/L per 6 months
Arm II (Supervised Exercise Separately)Inflammation-hsCRPPartner: Baseline-6mo-0.11 mg/L per 6 months
Arm II (Supervised Exercise Separately)Inflammation-hsCRPSurvivor: 6mo-12mo-0.20 mg/L per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-hsCRPPartner: 6mo-12mo-0.03 mg/L per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-hsCRPSurvivor: 6mo-12mo0.13 mg/L per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-hsCRPPartner: Baseline-6mo-0.04 mg/L per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-hsCRPSurvivor: Baseline-6mo-0.05 mg/L per 6 months
Secondary

Inflammation-TNF Alpha

Measured by serum levels of tumor necrosis factor alpha (TNF alpha) obtained from a fasting blood sample.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Inflammation-TNF AlphaSurvivor: Baseline-6mo-0.01 pg/mL per 6 months
Arm I (Supervised Exercise Together)Inflammation-TNF AlphaPartner: Baseline-6mo-0.02 pg/mL per 6 months
Arm I (Supervised Exercise Together)Inflammation-TNF AlphaPartner: 6mo-12mo0.00 pg/mL per 6 months
Arm I (Supervised Exercise Together)Inflammation-TNF AlphaSurvivor: 6mo-12mo-0.01 pg/mL per 6 months
Arm II (Supervised Exercise Separately)Inflammation-TNF AlphaSurvivor: Baseline-6mo-0.02 pg/mL per 6 months
Arm II (Supervised Exercise Separately)Inflammation-TNF AlphaSurvivor: 6mo-12mo-0.02 pg/mL per 6 months
Arm II (Supervised Exercise Separately)Inflammation-TNF AlphaPartner: Baseline-6mo-0.02 pg/mL per 6 months
Arm II (Supervised Exercise Separately)Inflammation-TNF AlphaPartner: 6mo-12mo0.00 pg/mL per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-TNF AlphaPartner: Baseline-6mo0.00 pg/mL per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-TNF AlphaSurvivor: Baseline-6mo-0.03 pg/mL per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-TNF AlphaSurvivor: 6mo-12mo-0.01 pg/mL per 6 months
Arm III (Unsupervised Exercise Separately)Inflammation-TNF AlphaPartner: 6mo-12mo0.03 pg/mL per 6 months
Secondary

Objective Physical Function

Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are total number of individuals (survivors + partners)

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Objective Physical FunctionSurvivor: 6mo-12mo-0.03 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Objective Physical FunctionSurvivor: Baseline-6mo0.75 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Objective Physical FunctionPartner: Baseline-6mo0.15 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Objective Physical FunctionPartner: 6mo-12mo0.11 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Objective Physical FunctionPartner: 6mo-12mo-0.18 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Objective Physical FunctionPartner: Baseline-6mo0.82 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Objective Physical FunctionSurvivor: Baseline-6mo0.86 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Objective Physical FunctionSurvivor: 6mo-12mo-0.07 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Objective Physical FunctionSurvivor: Baseline-6mo0.73 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Objective Physical FunctionSurvivor: 6mo-12mo-0.30 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Objective Physical FunctionPartner: Baseline-6mo0.73 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Objective Physical FunctionPartner: 6mo-12mo-0.11 Score on a scale per 6 months
Secondary

Quality of Life (QOL): QLQ-C30 - Emotional Functioning

Measures QOL in cancer patients including subscales of emotional functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.

Time frame: Baseline, 3, 6, 12 months

Population: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: Baseline-6mo4.18 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: 6mo-12mo-0.34 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: 6mo-12mo-0.39 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: Baseline-6mo1.82 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: Baseline-6mo4.67 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Emotional FunctioningSurvivor: 6mo-12mo-1.99 Score on a scale per 6 months
Secondary

Quality of Life (QOL): QLQ-C30 - Physical Functioning

Measures QOL in cancer patients including subscales of physical functioning. Scores range from 0-100 for overall QOL and subscales where higher scores indicate better functioning.

Time frame: Baseline, 3, 6 and 12 months

Population: Overall number of participants analyzed are survivors only since this scale is cancer survivor specific.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: Baseline-6mo2.12 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: 6mo-12mo-1.44 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: Baseline-6mo1.23 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: 6mo-12mo-0.30 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: Baseline-6mo1.26 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): QLQ-C30 - Physical FunctioningSurvivor: 6mo-12mo1.74 Score on a scale per 6 months
Secondary

Quality of Life (QOL): SF-36 Physical Function Subscale

The SF-36 measures quality of life using 8 subscales: perceived physical function, role limitations due to physical problems, social functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. All subscales have possible scores from 0-100, with items from each subscale averaged together. Low scores indicate worse physical functioning, while higher scores indicate better physical functioning.

Time frame: Baseline, 3, 6 and 12 months

Population: This measure had a significant amount of missing data for partners (due to a survey logic error) so the total sample size is reduced.

ArmMeasureGroupValue (MEAN)
Arm I (Supervised Exercise Together)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: 6mo-12mo-0.89 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: Baseline-6mo1.73 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: Baseline-6mo1.81 Score on a scale per 6 months
Arm I (Supervised Exercise Together)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: 6mo-12mo-0.76 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: Baseline-6mo1.94 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: 6mo-12mo-0.04 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: 6mo-12mo-0.56 Score on a scale per 6 months
Arm II (Supervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: Baseline-6mo2.47 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: 6mo-12mo1.02 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: 6mo-12mo-0.81 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscalePartner: Baseline-6mo0.12 Score on a scale per 6 months
Arm III (Unsupervised Exercise Separately)Quality of Life (QOL): SF-36 Physical Function SubscaleSurvivor: Baseline-6mo0.96 Score on a scale per 6 months

Source: ClinicalTrials.gov · Data processed: Apr 19, 2026