A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)
NCT ID: NCT03500393
Last Updated: 2021-02-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
4 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-22
Study Completion Date
2021-01-23
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Lung Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Participants will be blind to study hypotheses, data collector will be blind to treatment assignment
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Unsupervised Exercise (UNSUP)
Intervention Type
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.
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.
Group Type
EXPERIMENTAL
Remotely Supervised Exercise (REM)
Intervention Type
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
Interventions
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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
Intervention Type
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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;
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Kathleen Lyons
Scientist, Psychiatry Research
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kathleen Lyons, ScD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth Hitchcock Medical Center
Hanover, New Hampshire, United States
Site Status
Countries
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United States
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D18012
Identifier Type: -
Identifier Source: org_study_id
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