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

Assessing the Feasibility of a Patient-centered 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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasm Malignant
• Intervention / Treatment: Behavioral: Prescribed Activity

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea	Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea.	change from pre- to post-intervention (week 12)
Depression	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Global Health Status	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Physical Functioning	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Role Functioning	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Emotional Functioning	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Fatigue	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Cognitive Functioning	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Nausea/Vomiting	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Pain	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.	change from pre- to post-intervention (week 12)
Change in Quality of Life: Social Functioning	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Dyspnea	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Insomnia	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Appetite Loss	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 from pre- to post-intervention (week 12)
Change in Quality of Life: Constipation	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.	change from pre- to post-intervention (week 12)
Change in Quality of Life: Diarrhea	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.	change from pre- to post-intervention (week 12)
Change in Quality of Life: Financial Difficulties	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.	change from pre- to post-intervention (week 12)
Moderate Aerobic Exercise	The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.	baseline to 12 weeks
Vigorous Aerobic Exercise	The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.	baseline to 12 weeks
Change in C-reactive Protein (CRP)	The investigators will obtain serum CRP, a marker of inflammation.	change from pre- to post-intervention (week 12)
Change in Leptin Level	The investigators will obtain serum leptin, a marker of glucose control. .	change from pre- to post-intervention (week 12)
Change in Insulin Level	The investigators will obtain serum insulin level, a measure of glucose control.	change from pre- to post-intervention (week 12)
Programmed Death - Ligand	The investigators will collect soluble PD- L1, a novel cancer marker.	change from pre- to post-intervention (week 12)
Programmed Cell Death (PD-1)	The investigators will collect soluble PD- 1, a novel cancer marker.	change from pre- to post-intervention (week 12)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Medical University of South Carolina; National Cancer Institute (NCI); VA Connecticut Healthcare System
• Investigators: Principal Investigator: Brett Bade, M.D., Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): May 24, 2020
• Study Completion (Actual): May 24, 2020

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2000022225; 1P50CA196530-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No