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Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer

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ClinicalTrials.gov Identifier: NCT03352245
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Medical University of South Carolina
VA Connecticut Healthcare System
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

Brief Summary:
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.

Condition or disease Intervention/treatment Phase
Lung Neoplasm Malignant Behavioral: Prescribed Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : May 24, 2020
Actual Study Completion Date : May 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2).
Behavioral: Prescribed Activity
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)

No Intervention: Control Group
Usual care group will receive standard of care management from their Oncologist.



Primary Outcome Measures :
  1. Overall step count [ Time Frame: baseline to 12 weeks ]
    Participants will wear a Fitbit wrist band that will record step count.

  2. Adherence to step count recommendations [ Time Frame: baseline to 12 weeks. ]
    Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable.


Secondary Outcome Measures :
  1. Quality of life (QoL). [ Time Frame: change from pre- to post-intervention (week 12) ]

    Assessed via self-report using the European Organisation for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales:

    5 functional scales (subscale range 0-100; higher score = better functioning) that measure physical, role, emotional, cognitive and social functioning.

    3 symptom scales (subscale range 0-100; higher score = better functioning) that measure fatigue, nausea/vomiting, and pain;

    6 scales, each with range 0-100; higher score = higher symptom burden, that measure dyspnea, appetite loss, constipation, diarrhea, and financial difficulties.

    1 global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life.


  2. Dyspnea [ Time Frame: change from pre- to post-intervention (week 12) ]
    Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea.

  3. Depression [ Time Frame: change from pre- to post-intervention (week 12) ]
    Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = "Not at all"; 1 = "Several days"; 2 = "More than half of days"; 3 = "Nearly every day"). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression.

  4. Moderate aerobic exercise [ Time Frame: baseline to 12 weeks ]
    The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

  5. Vigorous aerobic exercise [ Time Frame: baseline to 12 weeks ]
    The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

  6. Change in c-reactive protein (CRP) [ Time Frame: change from pre- to post-intervention (week 12) ]
    The investigators will obtain serum CRP, a marker of inflammation.

  7. Change in insulin level [ Time Frame: change from pre- to post-intervention (week 12) ]
    The investigators will obtain serum insulin level, a measure of glucose control.

  8. Change in leptin level [ Time Frame: change from pre- to post-intervention (week 12) ]
    The investigators will obtain serum leptin, a marker of glucose control. .

  9. Programmed cell death (PD-1) [ Time Frame: change from pre- to post-intervention (week 12) ]
    The investigators will collect soluble PD- 1, a novel cancer marker.

  10. Programmed death - ligand [ Time Frame: change from pre- to post-intervention (week 12) ]
    The investigators will collect soluble PD- L1, a novel cancer marker.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
  • Approval of the treating clinician
  • Adult patients (age >21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
  • Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
  • Low activity level as judged by a brief physical activity questionnaire (i.e., <150 minutes/week of moderate-intensity exercise, <75 minutes/week of vigorous aerobic exercise, or an equivalent combination).

Exclusion Criteria:

  • Memory impairment (as judged by the treating clinician)
  • Communication impairment (as judged by the treating clinician)
  • Treating clinician's request not to alter physical activity
  • Physical inability to safely walk (as judged by the treating clinician)

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): NCT03352245


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Medical University of South Carolina
VA Connecticut Healthcare System
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brett Bade, M.D. Yale University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03352245    
Other Study ID Numbers: 2000022225
1P50CA196530-01 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
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
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases