Lung Neoplasm Malignant
Conditions
Brief summary
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of \>50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
Interventions
BEHAVIORALPrescribed Activity
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
Sponsors
Medical University of South Carolina
VA Connecticut Healthcare System
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC) * Approval of the treating clinician * Adult patients (age \>21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA) * Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone. * Low activity level as judged by a brief physical activity questionnaire (i.e., \<150 minutes/week of moderate-intensity exercise, \<75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
Exclusion criteria
* Memory impairment (as judged by the treating clinician) * Communication impairment (as judged by the treating clinician) * Treating clinician's request not to alter physical activity * Physical inability to safely walk (as judged by the treating clinician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Step Count | baseline to 12 weeks | Participants will wear a Fitbit wrist band that will record step count. |
| Number of Weeks Participants Adhered to Step Count Recommendations | baseline to 12 weeks. | Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of usable weeks). A week is considered usable if 5/7 days of step counts are available, and days with \<200 steps/day are considered not usable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | change from pre- to post-intervention (week 12) | Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = Not at all; 1 = Several days; 2 = More than half of days; 3 = Nearly every day). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression. |
| Change in Quality of Life: Global Health Status | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales: Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life. |
| Change in Quality of Life: Physical Functioning | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning. The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Role Functioning | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning. The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Emotional Functioning | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning. The range of score is 0-100; higher score = better functioning. |
| Programmed Death - Ligand | change from pre- to post-intervention (week 12) | The investigators will collect soluble PD- L1, a novel cancer marker. |
| Programmed Cell Death (PD-1) | change from pre- to post-intervention (week 12) | The investigators will collect soluble PD- 1, a novel cancer marker. |
| Change in Quality of Life: Fatigue | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue. The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Cognitive Functioning | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning. The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Nausea/Vomiting | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Pain | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain. The range of score is 0-100; higher score = better functioning. |
| Change in Insulin Level | change from pre- to post-intervention (week 12) | The investigators will obtain serum insulin level, a measure of glucose control. |
| Change in Quality of Life: Dyspnea | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea. The range of score is 0-100; higher score = higher symptoms burden. |
| Change in Quality of Life: Insomnia | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia. The range of score is 0-100; higher score = better functioning. |
| Change in Quality of Life: Appetite Loss | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden. |
| Change in Quality of Life: Constipation | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation. The range of score is 0-100; higher score = higher symptoms burden. |
| Change in Quality of Life: Diarrhea | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea. The range of score is 0-100; higher score = higher symptoms burden. |
| Change in Quality of Life: Financial Difficulties | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties. The range of score is 0-100; higher score = higher symptoms burden. |
| Moderate Aerobic Exercise | baseline to 12 weeks | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. |
| Vigorous Aerobic Exercise | baseline to 12 weeks | The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes. |
| Change in C-reactive Protein (CRP) | change from pre- to post-intervention (week 12) | The investigators will obtain serum CRP, a marker of inflammation. |
| Change in Leptin Level | change from pre- to post-intervention (week 12) | The investigators will obtain serum leptin, a marker of glucose control. . |
| Change in Quality of Life: Social Functioning | change from pre- to post-intervention (week 12) | Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning. The range of score is 0-100; higher score = better functioning. |
| Dyspnea | change from pre- to post-intervention (week 12) | Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).
Prescribed Activity: Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) | 20 |
| Control Group Usual care group will receive standard of care management from their Oncologist. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 66.55 years STANDARD_DEVIATION 7.28 | 63.20 years STANDARD_DEVIATION 63.5 | 64.88 years STANDARD_DEVIATION 8.69 |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Female | 12 Participants | 18 Participants | 30 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 0 / 20 |
| serious Total, serious adverse events | 3 / 20 | 1 / 20 |
Outcome results
Primary
Number of Weeks Participants Adhered to Step Count Recommendations
Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of usable weeks). A week is considered usable if 5/7 days of step counts are available, and days with \<200 steps/day are considered not usable.
Time frame: baseline to 12 weeks.
Population: This outcome was measured only in the intervention group. The 19 participants were each followed for 12 weeks. Thus 19 participants were followed for a total of 228 weeks.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intervention Group | Number of Weeks Participants Adhered to Step Count Recommendations | 47 Weeks |
Primary
Overall Step Count
Participants will wear a Fitbit wrist band that will record step count.
Time frame: baseline to 12 weeks
Population: This outcome was measured only in the intervention group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Group | Overall Step Count | Baseline | 4707 Steps |
| Intervention Group | Overall Step Count | 6 weeks | 5605 Steps |
| Intervention Group | Overall Step Count | 12 weeks | 4606 Steps |
Secondary
Change in C-reactive Protein (CRP)
The investigators will obtain serum CRP, a marker of inflammation.
Time frame: change from pre- to post-intervention (week 12)
Population: Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in C-reactive Protein (CRP) | -1,381.34 ng/mL | Standard Deviation 682.02 |
| Control Group | Change in C-reactive Protein (CRP) | -1,242.47 ng/mL | Standard Deviation 918.9 |
Secondary
Change in Insulin Level
The investigators will obtain serum insulin level, a measure of glucose control.
Time frame: change from pre- to post-intervention (week 12)
Population: Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Insulin Level | 5.08 uIU/mL | Standard Deviation 7.29 |
| Control Group | Change in Insulin Level | 8.32 uIU/mL | Standard Deviation 7.01 |
Secondary
Change in Leptin Level
The investigators will obtain serum leptin, a marker of glucose control. .
Time frame: change from pre- to post-intervention (week 12)
Population: Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Leptin Level | 0.34 ng/mL | Standard Deviation 3.28 |
| Control Group | Change in Leptin Level | -3.31 ng/mL | Standard Deviation 3.5 |
Secondary
Change in Quality of Life: Appetite Loss
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Appetite Loss | -4.16 units on a scale | Standard Error 6.6 |
| Control Group | Change in Quality of Life: Appetite Loss | 4.95 units on a scale | Standard Error 6.73 |
p-value: 0.29Mixed Models Analysis
Secondary
Change in Quality of Life: Cognitive Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Cognitive Functioning | 0.41 units on a scale | Standard Error 2.26 |
| Control Group | Change in Quality of Life: Cognitive Functioning | 2.47 units on a scale | Standard Error 2.31 |
p-value: 0.515Mixed Models Analysis
Secondary
Change in Quality of Life: Constipation
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation. The range of score is 0-100; higher score = higher symptoms burden.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Constipation | -1.21 units on a scale | Standard Error 4.02 |
| Control Group | Change in Quality of Life: Constipation | -11.19 units on a scale | Standard Error 4.11 |
p-value: 0.077Mixed Models Analysis
Secondary
Change in Quality of Life: Diarrhea
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea. The range of score is 0-100; higher score = higher symptoms burden.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Diarrhea | 0.14 units on a scale | Standard Error 3.32 |
| Control Group | Change in Quality of Life: Diarrhea | -5.13 units on a scale | Standard Error 3.39 |
p-value: 0.237Mixed Models Analysis
Secondary
Change in Quality of Life: Dyspnea
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea. The range of score is 0-100; higher score = higher symptoms burden.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Dyspnea | -6.19 units on a scale | Standard Error 4.88 |
| Control Group | Change in Quality of Life: Dyspnea | 7.12 units on a scale | Standard Error 4.99 |
p-value: 0.051Mixed Models Analysis
Secondary
Change in Quality of Life: Emotional Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Emotional Functioning | 2.68 units on a scale | Standard Error 2.89 |
| Control Group | Change in Quality of Life: Emotional Functioning | 3.11 units on a scale | Standard Error 2.95 |
p-value: 0.911Mixed Models Analysis
Secondary
Change in Quality of Life: Fatigue
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Fatigue | -4.43 units on a scale | Standard Error 4.85 |
| Control Group | Change in Quality of Life: Fatigue | 0.75 units on a scale | Standard Error 4.97 |
p-value: 0.456Mixed Models Analysis
Secondary
Change in Quality of Life: Financial Difficulties
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties. The range of score is 0-100; higher score = higher symptoms burden.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Financial Difficulties | 6.56 units on a scale | Standard Error 4.54 |
| Control Group | Change in Quality of Life: Financial Difficulties | 5.41 units on a scale | Standard Error 4.65 |
p-value: 0.861Mixed Models Analysis
Secondary
Change in Quality of Life: Global Health Status
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales: Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Global Health Status | 3.16 units on a scale | Standard Error 4.11 |
| Control Group | Change in Quality of Life: Global Health Status | -4.63 units on a scale | Standard Error 4.2 |
p-value: 0.166Mixed Models Analysis
Secondary
Change in Quality of Life: Insomnia
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Insomnia | 0.58 units on a scale | Standard Error 6.37 |
| Control Group | Change in Quality of Life: Insomnia | -3.49 units on a scale | Standard Error 6.52 |
p-value: 0.643Mixed Models Analysis
Secondary
Change in Quality of Life: Nausea/Vomiting
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Nausea/Vomiting | -2.44 units on a scale | Standard Error 4.18 |
| Control Group | Change in Quality of Life: Nausea/Vomiting | 6.21 units on a scale | Standard Error 4.28 |
p-value: 0.144Mixed Models Analysis
Secondary
Change in Quality of Life: Pain
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Pain | 1.67 units on a scale | Standard Error 4.77 |
| Control Group | Change in Quality of Life: Pain | 1.26 units on a scale | Standard Error 4.87 |
p-value: 0.948Mixed Models Analysis
Secondary
Change in Quality of Life: Physical Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Physical Functioning | 4.11 units on a scale | Standard Error 2.5 |
| Control Group | Change in Quality of Life: Physical Functioning | 4.74 units on a scale | Standard Error 2.54 |
p-value: 0.853Mixed Models Analysis
Secondary
Change in Quality of Life: Role Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Role Functioning | 8.09 units on a scale | Standard Error 5.33 |
| Control Group | Change in Quality of Life: Role Functioning | -8.95 units on a scale | Standard Error 5.45 |
p-value: 0.022Mixed Models Analysis
Secondary
Change in Quality of Life: Social Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning. The range of score is 0-100; higher score = better functioning.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life: Social Functioning | -4.22 units on a scale | Standard Error 5.38 |
| Control Group | Change in Quality of Life: Social Functioning | 4.40 units on a scale | Standard Error 5.5 |
p-value: 0.254Mixed Models Analysis
Secondary
Depression
Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = Not at all; 1 = Several days; 2 = More than half of days; 3 = Nearly every day). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Depression | -0.83 score on a scale | Standard Error 0.65 |
| Control Group | Depression | 0.31 score on a scale | Standard Error 0.68 |
p-value: 0.2Mixed Models Analysis
Secondary
Dyspnea
Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea.
Time frame: change from pre- to post-intervention (week 12)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Dyspnea | -0.04 score on a scale | Standard Error 0.15 |
| Control Group | Dyspnea | -0.07 score on a scale | Standard Error 0.15 |
p-value: 0.889Mixed Models Analysis
Secondary
Moderate Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Time frame: baseline to 12 weeks
Population: A 12 week outcome was not available for one subject in the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Moderate Aerobic Exercise | Baseline | 37.0 Minutes of activity per week | Standard Deviation 46.4 |
| Intervention Group | Moderate Aerobic Exercise | 12 weeks | 128.1 Minutes of activity per week | Standard Deviation 212.4 |
| Control Group | Moderate Aerobic Exercise | Baseline | 58.8 Minutes of activity per week | Standard Deviation 55.8 |
| Control Group | Moderate Aerobic Exercise | 12 weeks | 75.3 Minutes of activity per week | Standard Deviation 111.8 |
Secondary
Programmed Cell Death (PD-1)
The investigators will collect soluble PD- 1, a novel cancer marker.
Time frame: change from pre- to post-intervention (week 12)
Population: Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Programmed Cell Death (PD-1) | 152.76 pg/mL | Standard Deviation 45.51 |
| Control Group | Programmed Cell Death (PD-1) | -67.03 pg/mL | Standard Deviation 41.49 |
Secondary
Programmed Death - Ligand
The investigators will collect soluble PD- L1, a novel cancer marker.
Time frame: change from pre- to post-intervention (week 12)
Population: Only n=10 patients provided baseline and follow-up samples; 6 in the intervention group and 4 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Programmed Death - Ligand | 1.22 pg/mL | Standard Deviation 8.18 |
| Control Group | Programmed Death - Ligand | -11.08 pg/mL | Standard Deviation 11.17 |
Secondary
Vigorous Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Time frame: baseline to 12 weeks
Population: A 12 week outcome was not available for one subject in the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Vigorous Aerobic Exercise | Baseline | 0.0 Minutes of activity per week | Standard Deviation 0 |
| Intervention Group | Vigorous Aerobic Exercise | 12 weeks | 32.0 Minutes of activity per week | Standard Deviation 82.5 |
| Control Group | Vigorous Aerobic Exercise | Baseline | 0.0 Minutes of activity per week | Standard Deviation 0 |
| Control Group | Vigorous Aerobic Exercise | 12 weeks | 17.4 Minutes of activity per week | Standard Deviation 75.7 |