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feasibility of study recruitment
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The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation.
The research team adopts an overtly pragmatic approach where our design choices are made to enhance external validity and create a parsimonious intervention that can be integrated into busy clinical practices. This is a pilot study and is not designed to definitively provide evidence for a treatment effect, but rather to establish feasibility and to optimize the intervention and study procedures in preparation for a larger trial. We will conduct a pilot RCT comparing a remotely supervised exercise program (REM) to an unsupervised exercise program (UNSUP). Data will be collected upon enrollment (T0; at least 2 weeks prior to beginning chemoradiation), immediately prior to chemoradiation (T1), immediately post-chemoradiation (T2) and 1-month post-chemoradiation (T3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unsupervised Exercise (UNSUP) | Active Comparator | The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription. |
|
| Remotely Supervised Exercise (REM) | Experimental | The REM program is designed to function as an Acceptance-based health coaching intervention and will utilize theory-based behavior change techniques (i.e., goal setting/action planning, self-monitoring, receiving feedback, and reviewing relevant goals in the light of feedback) to promote adoption and adherence to the exercise prescription. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remotely Supervised Exercise (REM) | Behavioral | REM is designed to follow in the tradition of stepped care behavioral interventions. As such, participants who are successfully engaging in the prescribed exercise are provided minimal and automated encouragement and praise. Participants who demonstrate less adherence are given interventions that are tailored in content and intensity, depending on the level of success and the nature of the barriers to success |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and retention statistics | Number of participants enrolled/number of patients eligible; Number completing all data collection/Number enrolled; Number adhering to randomization/number enrolled; Number withdrawn/number enrolled | Time 3, One month after completing chemoradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes spent in exercise | Objective measure of adherence to exercise prescription; collected from fitness device | Time 3, One month after completing chemoradiation |
| 6-minute walk test | Observational measure of aerobic capacity (measures how far you can walk in six minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Acceptance Questionnaire | To explore the hypothesized mechanism underlying the effect of the intervention on exercise adherence we will measure psychological flexibility. The Physical Activity Acceptance Questionnaire (PAAQ)61 is a 10-item scale used to measure a person's ability to accept physical and psychological discomfort in the context of exercise. All items on the PAAQ are rated on a 7-point Likert scale scored, 1 = strongly disagree to 7 = strongly agree. Psychological flexibility is a stance of openness to the present experience (i.e., one's thoughts and feelings) without attempts to modify, suppress, or terminate that experience in any way. Responses to these items were summed to yield PAAQ total scores (at each time point) ranging from 10 - 70 where higher scores represent stronger experiential acceptance. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Lyons, ScD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Hanover | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Cancer Society. Cancer Facts and Figures 2016. Atlanta, GA2016 | ||
| 10561343 | Background | Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692. | |
| 20363001 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.
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Participants will be blind to study hypotheses, data collector will be blind to treatment assignment
|
| Unsupervised Exercise (UNSUP) | Behavioral | The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription. |
|
| Time 3, One month after completing chemoradiation |
| Timed up-and-go test | Observational measure of functional capacity/balance and agility (measures how long it takes to rise walk three meters, turn and sit) | Time 3, One month after completing chemoradiation |
| Five times sit-to-stand test | Observational measure of functional capacity/lower extremity strength (measures how long it take to rise from and sit down in chair five times) | Time 3, One month after completing chemoradiation |
| Forced expiratory volume in 1 second | Pulmonary function will be measured by forced expiratory volume in 1 second (FEV1). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3). | Time 3, One month after completing chemoradiation |
| Diffusion capacity | Pulmonary function will be measured by the diffusing capacity of lungs for carbon monoxide (DLCO). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3). | Time 3, One month after completing chemoradiation |
| Forced vital capacity | Pulmonary function will be measured by forced vital capacity (FVC). This will be measured by a pulmonary medicine technician as part of the pre-chemoradiation (T0) exam and 1-month post-treatment (T3). | Time 3, One month after completing chemoradiation |
| Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS) | The 10-item physical function scale of the PROMIS Item Bank36 will be administered to the participant by the research assistant. The items ask respondents to determine the degree to which health interferes with mobility and daily living tasks. The scale has an internal reliability coefficient of 0.81 and was found to correlate positively with quality of life and negatively with pain impact. Higher scores indicate better physical function. | Time 3, One month after completing chemoradiation |
| Pittsburgh Sleep Quality Index | From the actigraphy data from the Garmin fitness device, we can calculate sleep onset latency (SOL), total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE). It is expected that increased exercise in cancer patients will follow by decreased SOL and WASO, increased TST and SE, and improvements in subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) is a widely used measure of sleep quality, in the time frame of 2 weeks prior to the assessment. PSQI assesses a range of sleep disturbances, including symptoms of insomnia, symptoms of sleep-related breathing disorders, use of sleep medications, etc. PSQI score over 5 is indicative of significant sleep disturbances. We would expect that PSQI score would decrease following increased exercise in cancer patients. | Time 3, One month after completing chemoradiation |
| Functional Assessment of Cancer Therapy-fatigue scale | The Functional Assessment of Cancer Treatment- Fatigue (FACT-F) instrument will be used to measure quality of life and, specifically, effects of cancer-related fatigue upon quality of life .37 The FACT-F is a 40-item self-report measure of health-related quality of life specifically designed for cancer patients. The first 27 items of the tool represent the general version of the FACT (FACT-G) which assesses perceived well-being in physical, social, emotional, and functional domains. The remainder of the tool addresses concerns directly relevant to fatigue. Higher scores indicate higher quality of life. | Time 3, One month after completing chemoradiation |
| Dose reductions | Medical record audits will be conducted to determine the degree to which participants received the prescribed regimen of chemoradiation (performed at T2). | Time 3, One month after completing chemoradiation |
| Grip strength | Grip strength has been found to effectively identify people with clinically significant weakness that correlates with disability.60 Using a JAMAR Handheld Dynamometer, the subject will hold the device in their dominant hand, with the arm at right angles and the elbow by the side of the body. No other body movement is allowed. The subject squeezes the dynamometer with maximum isometric effort and maintained for about 5 seconds. The subject should be strongly encouraged to give maximum effort. The best result from several trials for each hand is recorded with at least 15 seconds recovery between each effort. | Time 3, one month after completing chemoradiation |
| Time 2, Assessment immediately after completing chemoradiation |
| Lymphocyte subsets | To explore the possible mechanisms underlying the effect of exercise, we will collect peripheral blood samples to analyze lymphocyte subsets, cytokines, and stress hormones. Flow cytometry will be used to analyze Total CD3+cells, Total CD4+ and CD8 cells and Treg populations in peripheral blood. Plasma/Serum will be stored for batch multi-plex ELISA for pro-and anti-inflammatory cytokine and stress hormone analyses | Time 3, One month after completing chemoradiation |
| Inflammatory cytokines | To explore the possible mechanisms underlying the effect of exercise, we will collect peripheral blood samples to analyze lymphocyte subsets, cytokines, and stress hormones. Flow cytometry will be used to analyze Total CD3+cells, Total CD4+ and CD8 cells and Treg populations in peripheral blood. Plasma/Serum will be stored for batch multi-plex ELISA for pro-and anti-inflammatory cytokine and stress hormone analyses | Time 3, One month after completing chemoradiation |
| Stress hormones | To explore the possible mechanisms underlying the effect of exercise, we will collect peripheral blood samples to analyze lymphocyte subsets, cytokines, and stress hormones. Flow cytometry will be used to analyze Total CD3+cells, Total CD4+ and CD8 cells and Treg populations in peripheral blood. Plasma/Serum will be stored for batch multi-plex ELISA for pro-and anti-inflammatory cytokine and stress hormone analyses | Time 3, One month after completing chemoradiation |
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| Background | Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-291. |
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| 20821373 | Background | Hegel MT, Lyons KD, Hull JG, Kaufman P, Urquhart L, Li Z, Ahles TA. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy. Psychooncology. 2011 Oct;20(10):1092-101. doi: 10.1002/pon.1830. Epub 2010 Sep 5. |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |