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

Not Applicable

Completed

• Conditions: Lung Neoplasm Malignant
• Interventions: Behavioral: Prescribed Activity

• Registration Number: NCT03352245
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-24
• Study Start: 2018-11-26
• Primary Completion: 2020-05-24
• Study Completion: 2020-05-24
• Results First Submitted: 2021-04-23
• Results First Submitted QC: 2021-05-18
• Results First Posted: 2021-05-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Prescribed Activity	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).

Primary Outcome Measures

Name	Time	Method
Number of Weeks Participants Adhered to Step Count Recommendations	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.
Overall Step Count	baseline to 12 weeks	Participants will wear a Fitbit wrist band that will record step count.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life: Nausea/Vomiting	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.
Change in Quality of Life: Pain	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.
Dyspnea	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.
Depression	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.
Change in Quality of Life: Global Health Status	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.
Change in Quality of Life: Role Functioning	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.
Change in Quality of Life: Emotional Functioning	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.
Change in Quality of Life: Fatigue	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.
Change in Quality of Life: Physical Functioning	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.
Change in Quality of Life: Cognitive Functioning	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.
Change in Quality of Life: Social Functioning	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.
Change in Quality of Life: Dyspnea	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.
Change in Quality of Life: Insomnia	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.
Change in Quality of Life: Appetite Loss	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.
Change in C-reactive Protein (CRP)	change from pre- to post-intervention (week 12)	The investigators will obtain serum CRP, a marker of inflammation.
Change in Quality of Life: Constipation	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.
Vigorous Aerobic Exercise	baseline to 12 weeks	The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Change in Quality of Life: Diarrhea	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.
Moderate Aerobic Exercise	baseline to 12 weeks	The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Change in Leptin Level	change from pre- to post-intervention (week 12)	The investigators will obtain serum leptin, a marker of glucose control. .
Change in Insulin Level	change from pre- to post-intervention (week 12)	The investigators will obtain serum insulin level, a measure of glucose control.
Programmed Death - Ligand	change from pre- to post-intervention (week 12)	The investigators will collect soluble PD- L1, a novel cancer marker.
Change in Quality of Life: Financial Difficulties	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.
Programmed Cell Death (PD-1)	change from pre- to post-intervention (week 12)	The investigators will collect soluble PD- 1, a novel cancer marker.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States