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Trial record 2 of 4 for:    19916637 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03500393
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kathleen Lyons, Dartmouth-Hitchcock Medical Center

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
Lung Cancer Behavioral: Remotely Supervised Exercise (REM) Behavioral: Unsupervised Exercise (UNSUP) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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.
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 : June 22, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Minutes spent in exercise [ Time Frame: Time 3, One month after completing chemoradiation ]
    Objective measure of adherence to exercise prescription; collected from fitness device

  2. 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)

  3. 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)

  4. 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)

  5. 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).

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500393


Contacts
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Contact: Research Nurse 800-639-6918 cancer.research.nurse@dartmouth.edu
Contact: Kayla Fay 603-650-8537 Kayla.A.Fay@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Hanover, New Hampshire, United States, 03756
Contact: Kayla Fay    603-650-8537    Kayla.A.Fay@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Kathleen Lyons, ScD Dartmouth-Hitchcock Medical Center

Publications:
American Cancer Society. Cancer Facts and Figures 2016. Atlanta, GA2016
American College of Sports Medicine. ACSM's Guidelines for Exercise Testing and Prescription. 9th ed. Philadephia: Lippincott, Williams, and Wilkins; 2013.
Stevens CJ. Get ACTive! A randomized controlled trial of feasibility and effectiveness of an acceptance-based behavioral intervention to promote exercise adoption and maintenance. 2016.
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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Responsible Party: Kathleen Lyons, Scientist, Psychiatry Research, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03500393     History of Changes
Other Study ID Numbers: D18012
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases