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

• ClinicalTrials.gov Identifier: NCT03352245
• Recruitment Status: Completed
• First Posted: November 24, 2017
• Results First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Sponsor: Yale University
• Collaborators: Medical University of South Carolina; VA Connecticut Healthcare System; National Cancer Institute (NCI)
• Information provided by (Responsible Party): Yale University

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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. 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 Outcome Measures :

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Principal Investigator: Brett Bade, M.D.; Yale University

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bade BC, Gan G, Li F, Lu L, Tanoue L, Silvestri GA, Irwin ML. "Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0.

• 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
• Results First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases