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Completed

NCT Number: NCT03352245

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

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.

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Key information

Conditions

Lung Neoplasm Malignant Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prescribed Activity

Behavioral

Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)

Primary outcomes

  1. Overall Step Count

    Time frame: baseline to 12 weeks

    Participants will wear a Fitbit wrist band that will record step count.

  2. Number of Weeks Participants Adhered 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 outcomes

  1. 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.

  2. 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.

  3. Change in Quality of Life: Global Health Status

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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:

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

  4. Change in Quality of Life: Physical Functioning

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the 5 functional scales measure physical functioning.

    The range of score is 0-100; higher score = better functioning.

  5. Change in Quality of Life: Role Functioning

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the 5 functional scales measures role functioning.

    The range of score is 0-100; higher score = better functioning.

  6. Change in Quality of Life: Emotional Functioning

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the 5 functional scales measures emotional functioning.

    The range of score is 0-100; higher score = better functioning.

  7. Change in Quality of Life: Fatigue

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the symptom scale measures fatigue.

    The range of score is 0-100; higher score = better functioning.

  8. Change in Quality of Life: Cognitive Functioning

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the 5 functional scales measures cognitive functioning.

    The range of score is 0-100; higher score = better functioning.

  9. Change in Quality of Life: Nausea/Vomiting

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning.

  10. Change in Quality of Life: Pain

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the symptom scale measures pain.

    The range of score is 0-100; higher score = better functioning.

  11. Change in Quality of Life: Social Functioning

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the 5 functional scales measures social functioning.

    The range of score is 0-100; higher score = better functioning.

  12. Change in Quality of Life: Dyspnea

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure dyspnea.

    The range of score is 0-100; higher score = higher symptoms burden.

  13. Change in Quality of Life: Insomnia

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure insomnia.

    The range of score is 0-100; higher score = better functioning.

  14. Change in Quality of Life: Appetite Loss

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden.

  15. Change in Quality of Life: Constipation

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure constipation.

    The range of score is 0-100; higher score = higher symptoms burden.

  16. Change in Quality of Life: Diarrhea

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure diarrhea.

    The range of score is 0-100; higher score = higher symptoms burden.

  17. Change in Quality of Life: Financial Difficulties

    Time frame: change from pre- to post-intervention (week 12)

    Assessed via self-report using the European Organization 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. One of the scales measure financial difficulties.

    The range of score is 0-100; higher score = higher symptoms burden.

  18. Moderate Aerobic Exercise

    Time frame: baseline to 12 weeks

    The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

  19. Vigorous Aerobic Exercise

    Time frame: baseline to 12 weeks

    The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.

  20. 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.

  21. 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. .

  22. 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.

  23. Programmed Death - Ligand

    Time frame: change from pre- to post-intervention (week 12)

    The investigators will collect soluble PD- L1, a novel cancer marker.

  24. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Medical University of South Carolina
  • National Cancer Institute (NCI)
  • VA Connecticut Healthcare System

Registry information

Official study title

Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2017
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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