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A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03500393
Collaborator
(none)
4
Enrollment
1
Location
2
Arms
31.1
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Remotely Supervised Exercise (REM)
  • Behavioral: Unsupervised Exercise (UNSUP)
 N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will be blind to study hypotheses, data collector will be blind to treatment assignment
Primary Purpose:
Other
Official Title:
A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation
Actual Study Start Date :
Jun 22, 2018
Actual Primary Completion Date :
Jan 23, 2021
Actual Study Completion Date :
Jan 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Unsupervised Exercise (UNSUP)

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.

Behavioral: Unsupervised Exercise (UNSUP)
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.
Experimental: Remotely Supervised Exercise (REM)

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.

Behavioral: Remotely Supervised Exercise (REM)
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

Outcome Measures

Primary Outcome Measures

  1. Recruitment and retention statistics [Time 3, One month after completing chemoradiation]

    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

Secondary Outcome Measures

  1. Minutes spent in exercise [Time 3, One month after completing chemoradiation]

    Objective measure of adherence to exercise prescription; collected from fitness device

  2. 6-minute walk test [Time 3, One month after completing chemoradiation]

    Observational measure of aerobic capacity (measures how far you can walk in six minutes)

  3. Timed up-and-go test [Time 3, One month after completing chemoradiation]

    Observational measure of functional capacity/balance and agility (measures how long it takes to rise walk three meters, turn and sit)

  4. Five times sit-to-stand test [Time 3, One month after completing chemoradiation]

    Observational measure of functional capacity/lower extremity strength (measures how long it take to rise from and sit down in chair five times)

  5. Forced expiratory volume in 1 second [Time 3, One month after completing chemoradiation]

    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).

  6. Diffusion capacity [Time 3, One month after completing chemoradiation]

    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).

  7. Forced vital capacity [Time 3, One month after completing chemoradiation]

    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).

  8. Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS) [Time 3, One month after completing chemoradiation]

    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.

  9. Pittsburgh Sleep Quality Index [Time 3, One month after completing chemoradiation]

    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.

  10. Functional Assessment of Cancer Therapy-fatigue scale [Time 3, One month after completing chemoradiation]

    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.

  11. Dose reductions [Time 3, One month after completing chemoradiation]

    Medical record audits will be conducted to determine the degree to which participants received the prescribed regimen of chemoradiation (performed at T2).

  12. Grip strength [Time 3, one month after completing chemoradiation]

    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.

Other Outcome Measures

  1. Physical Activity Acceptance Questionnaire [Time 2, Assessment immediately after completing chemoradiation]

    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.

  2. Lymphocyte subsets [Time 3, One month after completing chemoradiation]

    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

  3. Inflammatory cytokines [Time 3, One month after completing chemoradiation]

    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

  4. Stress hormones [Time 3, One month after completing chemoradiation]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;

  • Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;

  • Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;

  • Are English-speaking and able to provide voluntary, written consent;

  • Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;

Exclusion Criteria:

  • Life expectancy of < 12 months or are receiving hospice services;

  • Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;

  • Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;

  • Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;

  • Less than 2 weeks to the beginning of chemoradiation;

  • Physician discretion;

  • Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dartmouth Hitchcock Medical Center Hanover New Hampshire United States 03756

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Kathleen Lyons, ScD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kathleen Lyons, Scientist, Psychiatry Research, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT03500393
Other Study ID Numbers:
  • D18012
First Posted:
Apr 18, 2018
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Feb 2, 2021