Trial Outcomes & Findings for Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer (NCT NCT03352245)

NCT ID: NCT03352245

Last Updated: 2024-02-15

Results Overview

Participants will wear a Fitbit wrist band that will record step count.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: baseline to 12 weeks
• Results posted on: 2024-02-15

Participant Flow

Participant milestones

Measure	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)	Control Group Usual care group will receive standard of care management from their Oncologist.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer

Baseline characteristics by cohort

Measure	Intervention Group n=20 Participants 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)	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Total n=40 Participants Total of all reporting groups
Age, Continuous	66.55 years STANDARD_DEVIATION 7.28 • n=93 Participants	63.20 years STANDARD_DEVIATION 63.50 • n=4 Participants	64.88 years STANDARD_DEVIATION 8.69 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	18 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	2 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized White	18 Participants n=93 Participants	16 Participants n=4 Participants	34 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: This outcome was measured only in the intervention group.

Participants will wear a Fitbit wrist band that will record step count.

Outcome measures

Measure	Control Group Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=19 Participants 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)
Overall Step Count 6 weeks	—	5605 Steps
Overall Step Count 12 weeks	—	4606 Steps Interval 746.0 to
Overall Step Count Baseline	—	4707 Steps

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control Group Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=228 Weeks 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)
Number of Weeks Participants Adhered to Step Count Recommendations	—	47 Weeks

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=19 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Dyspnea	-0.07 score on a scale Standard Error 0.15	-0.04 score on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=19 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Depression	0.31 score on a scale Standard Error 0.68	-0.83 score on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Global Health Status	-4.63 units on a scale Standard Error 4.20	3.16 units on a scale Standard Error 4.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Physical Functioning	4.74 units on a scale Standard Error 2.54	4.11 units on a scale Standard Error 2.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Role Functioning	-8.95 units on a scale Standard Error 5.45	8.09 units on a scale Standard Error 5.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Emotional Functioning	3.11 units on a scale Standard Error 2.95	2.68 units on a scale Standard Error 2.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Fatigue	0.75 units on a scale Standard Error 4.97	-4.43 units on a scale Standard Error 4.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Cognitive Functioning	2.47 units on a scale Standard Error 2.31	0.41 units on a scale Standard Error 2.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Nausea/Vomiting	6.21 units on a scale Standard Error 4.28	-2.44 units on a scale Standard Error 4.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Pain	1.26 units on a scale Standard Error 4.87	1.67 units on a scale Standard Error 4.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Social Functioning	4.40 units on a scale Standard Error 5.50	-4.22 units on a scale Standard Error 5.38

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Dyspnea	7.12 units on a scale Standard Error 4.99	-6.19 units on a scale Standard Error 4.88

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Insomnia	-3.49 units on a scale Standard Error 6.52	0.58 units on a scale Standard Error 6.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Appetite Loss	4.95 units on a scale Standard Error 6.73	-4.16 units on a scale Standard Error 6.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Constipation	-11.19 units on a scale Standard Error 4.11	-1.21 units on a scale Standard Error 4.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Diarrhea	-5.13 units on a scale Standard Error 3.39	0.14 units on a scale Standard Error 3.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Change in Quality of Life: Financial Difficulties	5.41 units on a scale Standard Error 4.65	6.56 units on a scale Standard Error 4.54

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: A 12 week outcome was not available for one subject in the control group.

The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Moderate Aerobic Exercise Baseline	58.8 Minutes of activity per week Standard Deviation 55.8	37.0 Minutes of activity per week Standard Deviation 46.4
Moderate Aerobic Exercise 12 weeks	75.3 Minutes of activity per week Standard Deviation 111.8	128.1 Minutes of activity per week Standard Deviation 212.4

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: A 12 week outcome was not available for one subject in the control group.

The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

Outcome measures

Measure	Control Group n=20 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=20 Participants 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)
Vigorous Aerobic Exercise Baseline	0.0 Minutes of activity per week Standard Deviation 0.0	0.0 Minutes of activity per week Standard Deviation 0.0
Vigorous Aerobic Exercise 12 weeks	17.4 Minutes of activity per week Standard Deviation 75.7	32.0 Minutes of activity per week Standard Deviation 82.5

SECONDARY outcome

Timeframe: 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.

The investigators will obtain serum CRP, a marker of inflammation.

Outcome measures

Measure	Control Group n=4 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=6 Participants 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)
Change in C-reactive Protein (CRP)	-1,242.47 ng/mL Standard Deviation 918.90	-1,381.34 ng/mL Standard Deviation 682.02

SECONDARY outcome

Timeframe: 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.

The investigators will obtain serum leptin, a marker of glucose control. .

Outcome measures

Measure	Control Group n=4 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=6 Participants 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)
Change in Leptin Level	-3.31 ng/mL Standard Deviation 3.50	0.34 ng/mL Standard Deviation 3.28

SECONDARY outcome

Timeframe: 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.

The investigators will obtain serum insulin level, a measure of glucose control.

Outcome measures

Measure	Control Group n=4 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=6 Participants 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)
Change in Insulin Level	8.32 uIU/mL Standard Deviation 7.01	5.08 uIU/mL Standard Deviation 7.29

SECONDARY outcome

Timeframe: 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.

The investigators will collect soluble PD- L1, a novel cancer marker.

Outcome measures

Measure	Control Group n=4 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=6 Participants 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)
Programmed Death - Ligand	-11.08 pg/mL Standard Deviation 11.17	1.22 pg/mL Standard Deviation 8.18

SECONDARY outcome

Timeframe: 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.

The investigators will collect soluble PD- 1, a novel cancer marker.

Outcome measures

Measure	Control Group n=4 Participants Usual care group will receive standard of care management from their Oncologist.	Intervention Group n=6 Participants 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)
Programmed Cell Death (PD-1)	-67.03 pg/mL Standard Deviation 41.49	152.76 pg/mL Standard Deviation 45.51

Adverse Events

Intervention Group

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention Group n=20 participants at risk 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)	Control Group n=20 participants at risk Usual care group will receive standard of care management from their Oncologist.
Respiratory, thoracic and mediastinal disorders Pneumonia	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.
Endocrine disorders hyperthyroidism	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.
Musculoskeletal and connective tissue disorders Fall	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/20 • Twelve weeks.	5.0% 1/20 • Number of events 1 • Twelve weeks.

Other adverse events

Measure	Intervention Group n=20 participants at risk 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)	Control Group n=20 participants at risk Usual care group will receive standard of care management from their Oncologist.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.
Musculoskeletal and connective tissue disorders Ankle pain	5.0% 1/20 • Number of events 1 • Twelve weeks.	0.00% 0/20 • Twelve weeks.

Additional Information

Dr. Brett Bade

Yale University

Phone: 203 785 6670

Email: Brett.bade@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place