Skip to content

A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

Increasing Physical Activity Among Breast Cancer Survivors: Use of the ORBIT Model to Refine and Test a Novel Approach to Exercise Promotion Based on Affect-regulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04903249
Enrollment
37
Registered
2021-05-26
Start date
2021-08-10
Completion date
2022-06-13
Last updated
2023-07-27

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

Conditions

Breast Cancer

Brief summary

The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.

Interventions

BEHAVIORALCore Exercise Promotion Intervention

Participants are instructed to increase weekly time spent exercising to \>90 minutes over 12 weeks. Exercise will be defined as activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer * \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months * Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods * Willing to wear the ActiGraph monitor during assessment periods * Access to internet to complete REDCap survey assessments

Exclusion criteria

* Non-English speaking/not able to read English * Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+) * Currently pregnant * History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium) * Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8) * Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener) * Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Completed the Exit Interview12-weeks follow-up assessmentSemi-structured interview to assess participants' perceptions regarding their experience participating in the study.
Percentage of Sample With Valid Accelerometer Data at BaselineBaseline assessmentThe number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up2-weeks follow-up assessmentThe number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up6-weeks follow-up assessmentThe number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up12-weeks follow-up assessmentThe number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt CompletionBaseline through 12-weeks follow-up assessmentsThe percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure12-weeks follow-up assessmentA 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.

Secondary

MeasureTime frameDescription
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire12-weeks follow-up assessmentAn 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.
Study Retention at 2-weeks Follow-up2-weeks follow-up assessmentNumber of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 6-weeks Follow-up6-weeks follow-up assessmentNumber of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 12-weeks Follow-up12-weeks follow-up assessmentNumber of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up12-weeks follow-up assessmentThe research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

Other

MeasureTime frameDescription
Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)Baseline and 12-weeks follow-up assessmentsA 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise.
Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8aBaseline and 12-weeks follow-up assessmentsAn 8-item self-report measure with response options ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging from 1 (never) to 5 (always) over the past 7 days. Total scores range from 8 - 40. Higher scores reflect more fatigue.
Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise ScaleBaseline and 12-weeks follow-up assessmentsA 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise.
Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise ScaleBaseline and 12-weeks follow-up assessmentsA 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise.
Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health ScaleBaseline and 12-weeks follow-up assessmentsA 10-item self-report measure with response options ranging from 1 (poor/never/not at all) to 5 (excellent/completely/always) for items 1-9 and 0 (no pain) to 10 (worst pain imaginable) for the item 10. Total scores range from 9 - 45. Higher scores represent better health-related quality of life.
Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8aBaseline and 12-weeks follow-up assessmentsAn 8-item self-report measure with response options ranging from 1 (unable to do) to 5 (without any difficulty) and the degree to which health limits specific activities on a scale from 1 (cannot do) to 5 (not at all). Total scores range from 8 - 40. Higher scores reflect better physical function.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up2-weeks follow-up assessmentThe Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up6-weeks follow-up assessmentThe Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up12-weeks follow-up assessmentThe Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up2-weeks follow-up assessmentThe research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up6-weeks follow-up assessmentThe research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise QuestionnaireBaseline and 12-weeks follow-up assessmentsA 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.
Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)Baseline and 12-weeks follow-up assessmentsA single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.
Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions ScaleBaseline and 12-weeks follow-up assessmentsA 5-item self-report measure of intentions to engage in physical activity. Response options range from 1 (not at all likely) to 7 (very likely). Responses are summed and then averaged; total scores range from 1-7. Higher scores represent stronger intentions to engage in physical activity.
Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise ScaleBaseline and 12-weeks follow-up assessmentsA 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise.

Countries

United States

Participant flow

Pre-assignment details

1 participant signed consent but did not engage in any reach activities and no data was collected for this individual.

Participants by arm

ArmCount
Affect-regulated Exercise Prescription
Participants receive instructions to adjust their pace of exercise so that they feel fairly good or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling fairly bad or worse. If no intensity of exercise feels at least fairly good participants will be told to exercise at an intensity that feels as positive as possible. Core Exercise Promotion Intervention: Participants are instructed to increase weekly time spent exercising to \>90 minutes over 12 weeks. Exercise will be defined as activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period.
37
Total37

Baseline characteristics

CharacteristicAffect-regulated Exercise Prescription
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
11 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Age, Continuous57.81 years
STANDARD_DEVIATION 10.3
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
36 Participants
Region of Enrollment
United States
37 participants
Sex: Female, Male
Female
37 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 37
other
Total, other adverse events
0 / 37
serious
Total, serious adverse events
0 / 37

Outcome results

Primary

Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure

A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.

Time frame: 12-weeks follow-up assessment

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAcceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure3.31 score on a scaleStandard Deviation 0.53
Primary

Number of Participants Who Completed the Exit Interview

Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.

Time frame: 12-weeks follow-up assessment

Population: Participants who completed the exit interview

ArmMeasureValue (NUMBER)
Affect-regulated Exercise PrescriptionNumber of Participants Who Completed the Exit Interview30 participants
Primary

Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion

The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.

Time frame: Baseline through 12-weeks follow-up assessments

Population: Two of the N = 37 participants enrolled at baseline withdrew before starting EMA data collection. Thus, EMA data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure).

ArmMeasureValue (NUMBER)
Affect-regulated Exercise PrescriptionPercentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion84.83 percentage of EMA prompts completed
Primary

Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.

Time frame: 12-weeks follow-up assessment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Affect-regulated Exercise PrescriptionPercentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up28 Participants
Primary

Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.

Time frame: 2-weeks follow-up assessment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Affect-regulated Exercise PrescriptionPercentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up28 Participants
Primary

Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up

The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.

Time frame: 6-weeks follow-up assessment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Affect-regulated Exercise PrescriptionPercentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up28 Participants
Primary

Percentage of Sample With Valid Accelerometer Data at Baseline

The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.

Time frame: Baseline assessment

Population: Two of the N = 37 participants enrolled at baseline withdrew before starting accelerometer data collection. Thus, accelerometer data at baseline are available from N = 35 participants (i.e., the overall number of participants analyzed for this outcome measure).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Affect-regulated Exercise PrescriptionPercentage of Sample With Valid Accelerometer Data at Baseline33 Participants
Secondary

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up

The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

Time frame: 12-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 12-weeks follow-up. N = 28 participants had valid wear time at 12-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up32.97 minutes of daily MVPAStandard Deviation 40.17
Secondary

Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire

An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.

Time frame: 12-weeks follow-up assessment

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionSatisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire3.33 score on a scaleStandard Deviation 0.63
Secondary

Study Retention at 12-weeks Follow-up

Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.

Time frame: 12-weeks follow-up assessment

ArmMeasureValue (NUMBER)
Affect-regulated Exercise PrescriptionStudy Retention at 12-weeks Follow-up30 participants
Secondary

Study Retention at 2-weeks Follow-up

Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.

Time frame: 2-weeks follow-up assessment

ArmMeasureValue (NUMBER)
Affect-regulated Exercise PrescriptionStudy Retention at 2-weeks Follow-up30 participants
Secondary

Study Retention at 6-weeks Follow-up

Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.

Time frame: 6-weeks follow-up assessment

ArmMeasureValue (NUMBER)
Affect-regulated Exercise PrescriptionStudy Retention at 6-weeks Follow-up30 participants
Other Pre-specified

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up

The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

Time frame: 2-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 2-weeks follow-up. N = 28 participants had valid wear time at 2-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 2 Weeks Follow-up30.48 minutes of daily MVPAStandard Deviation 17.2
Other Pre-specified

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up

The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.

Time frame: 6-weeks follow-up assessment

Population: Valid wear accelerometer wear time was defined as 5 or more days of 600 minutes wear time at 6-weeks follow-up. N = 28 participants had valid wear time at 6-weeks follow-up, thus N = 28 is the overall number of participants analyzed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 6 Weeks Follow-up29.11 minutes of daily MVPAStandard Deviation 15.84
Other Pre-specified

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up

The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.

Time frame: 12-weeks follow-up assessment

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 12 Weeks Follow up17.13 minutes per dayStandard Deviation 16.77
Other Pre-specified

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up

The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.

Time frame: 2-weeks follow-up assessment

Population: Data was missing from N = 1 participant, total sample size at 2 weeks follow up was N = 30.

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 2 Weeks Follow up16.36 minutes per dayStandard Deviation 15.04
Other Pre-specified

Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up

The Godin Leisure-Time Exercise Questionnaire is a brief self-report measure that asks participants to report how many minutes they spent participating in moderate and vigorous physical activity on a given day. Participants will report total minutes of moderate-vigorous physical activity completed per day for 10-days. Average minutes of moderate-vigorous physical activity completed per day will be calculated.

Time frame: 6-weeks follow-up assessment

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionAverage Minutes of Daily Moderate-vigorous Physical Activity Measured Using The Godin Leisure-Time Exercise Questionnaire at 6 Weeks Follow up11.61 minutes per dayStandard Deviation 14.7
Other Pre-specified

Change in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale

A 4-item self-report measure of affective attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable affective attitudes about exercise.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Affective Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale-.36 score on a scaleStandard Deviation 1.78
p-value: 0.279t-test, 2 sided
Other Pre-specified

Change in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale

A 4-item self-report measure of instrumental attitudes for exercise. Response options range from -5 to 5. Responses are summed and then averaged; total scores range from -5 to 5. Higher scores more favorable instrumental attitudes about exercise.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Instrumental Attitudes About Exercise Using The Instrumental and Affective Attitudes About Exercise Scale-.49 score on a scaleStandard Deviation 1.33
p-value: 0.052t-test, 2 sided
Other Pre-specified

Change in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale

A 5-item self-report measure of intentions to engage in physical activity. Response options range from 1 (not at all likely) to 7 (very likely). Responses are summed and then averaged; total scores range from 1-7. Higher scores represent stronger intentions to engage in physical activity.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Intentions to Engage in Physical Activity Measured Using The Exercise Intentions Scale.27 score on a scaleStandard Deviation 1.49
p-value: 0.327t-test, 2 sided
Other Pre-specified

Change in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)

A 4-item self-report scale depicting intrinsic motivation for exercise. Response options range from 0 (not true for me) to 4 (very true for me). Responses are summed and then averaged; total scores range from 0-4. Higher scores indicate greater intrinsic motivation for exercise.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Intrinsic Motivation for Exercise Measured Using The Behavioral Regulations in Exercise Questionnaire (BREQ-2)-.14 score on a scaleStandard Deviation 0.96
p-value: 0.424t-test, 2 sided
Other Pre-specified

Change in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat)

A single item self-report measure that present six statements describing various levels of monthly physical activity. Response options range from 1 (I did not do much physical activity) to 5 (I did vigorous activities almost daily). Total scores range from 1-5. Higher scores reflect more vigorous, more frequent physical activities completed in the past month.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Physical Activity Category Completed in the Past Month Measured Using the Stanford Leisure-Time Activity Categorical Item (L-Cat).80 score on a scaleStandard Deviation 0.89
p-value: <0.001t-test, 2 sided
Other Pre-specified

Change in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale

A 13-item self-report measure of one's perceived capability to exercise regularly despite commonly identified barriers to participation. Response options range from 0 (not at all confident) to 100 (highly confident). Responses are summed and then averaged; total scores range from 0% - 100%, higher scores represent greater self-efficacy for exercise.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Self-efficacy for Exercise Measured Using The Barriers Specific Self-Efficacy for Exercise Scale-2.82 score on a scaleStandard Deviation 21.58
p-value: 0.479t-test, 2 sided
Other Pre-specified

Change in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire

A 6-item self-report measure of exercise performed over the last month and week. Two items range from 1 (never) to 7 (often) and four items range from 0 (0 days per week) to 7 (7 days per week). Total scores range from 2-21. Higher scores reflect higher levels of voluntary exercise behavior.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange in Voluntary Exercise Behavior Measured Using The Voluntary Exercise Questionnaire1.93 score on a scaleStandard Deviation 4.46
p-value: 0.025t-test, 2 sided
Other Pre-specified

Change Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a

An 8-item self-report measure with response options ranging from 1 (not at all) to 5 (very much) and fatigue interference ranging from 1 (never) to 5 (always) over the past 7 days. Total scores range from 8 - 40. Higher scores reflect more fatigue.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange Overtime in Cancer-related Fatigue Measured Using the PROMIS Fatigue Short Form 8a-1.50 units on a scaleStandard Deviation 5.4
p-value: 0.137t-test, 2 sided
Other Pre-specified

Change Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale

A 10-item self-report measure with response options ranging from 1 (poor/never/not at all) to 5 (excellent/completely/always) for items 1-9 and 0 (no pain) to 10 (worst pain imaginable) for the item 10. Total scores range from 9 - 45. Higher scores represent better health-related quality of life.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange Overtime in Health-related Quality of Life Measured Using the PROMIS Global Health Scale.60 score on a scaleStandard Deviation 3.07
p-value: 0.293t-test, 2 sided
Other Pre-specified

Change Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a

An 8-item self-report measure with response options ranging from 1 (unable to do) to 5 (without any difficulty) and the degree to which health limits specific activities on a scale from 1 (cannot do) to 5 (not at all). Total scores range from 8 - 40. Higher scores reflect better physical function.

Time frame: Baseline and 12-weeks follow-up assessments

ArmMeasureValue (MEAN)Dispersion
Affect-regulated Exercise PrescriptionChange Overtime in Physical Functioning Measured Using The PROMIS Physical Function Short Form 8a.40 score on a scaleStandard Deviation 4.24
p-value: 0.609t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026