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

January 28, 2021 updated by: Kathleen Lyons, Dartmouth-Hitchcock Medical Center

A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Hanover, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment and retention statistics
Time Frame: 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
Time 3, One month after completing chemoradiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes spent in exercise
Time Frame: Time 3, One month after completing chemoradiation
Objective measure of adherence to exercise prescription; collected from fitness device
Time 3, One month after completing chemoradiation
6-minute walk test
Time Frame: Time 3, One month after completing chemoradiation
Observational measure of aerobic capacity (measures how far you can walk in six minutes)
Time 3, One month after completing chemoradiation
Timed up-and-go test
Time Frame: 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)
Time 3, One month after completing chemoradiation
Five times sit-to-stand test
Time Frame: 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)
Time 3, One month after completing chemoradiation
Forced expiratory volume in 1 second
Time Frame: 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).
Time 3, One month after completing chemoradiation
Diffusion capacity
Time Frame: 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).
Time 3, One month after completing chemoradiation
Forced vital capacity
Time Frame: 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).
Time 3, One month after completing chemoradiation
Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)
Time Frame: 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.
Time 3, One month after completing chemoradiation
Pittsburgh Sleep Quality Index
Time Frame: 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.
Time 3, One month after completing chemoradiation
Functional Assessment of Cancer Therapy-fatigue scale
Time Frame: 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.
Time 3, One month after completing chemoradiation
Dose reductions
Time Frame: 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).
Time 3, One month after completing chemoradiation
Grip strength
Time Frame: 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.
Time 3, one month after completing chemoradiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Acceptance Questionnaire
Time Frame: 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.
Time 2, Assessment immediately after completing chemoradiation
Lymphocyte subsets
Time Frame: 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
Time 3, One month after completing chemoradiation
Inflammatory cytokines
Time Frame: 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
Time 3, One month after completing chemoradiation
Stress hormones
Time Frame: 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
Time 3, One month after completing chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2018

Primary Completion (Actual)

January 23, 2021

Study Completion (Actual)

January 23, 2021

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D18012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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