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

Primary Purpose

Lung Neoplasm Malignant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prescribed Activity
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasm Malignant

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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).

Usual care group will receive standard of care management from their Oncologist.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
Moderate Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Vigorous Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Change in C-reactive Protein (CRP)
The investigators will obtain serum CRP, a marker of inflammation.
Change in Leptin Level
The investigators will obtain serum leptin, a marker of glucose control. .
Change in Insulin Level
The investigators will obtain serum insulin level, a measure of glucose control.
Programmed Death - Ligand
The investigators will collect soluble PD- L1, a novel cancer marker.
Programmed Cell Death (PD-1)
The investigators will collect soluble PD- 1, a novel cancer marker.

Full Information

First Posted
November 20, 2017
Last Updated
May 18, 2021
Sponsor
Yale University
Collaborators
Medical University of South Carolina, VA Connecticut Healthcare System, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03352245
Brief Title
Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer
Official Title
Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
May 24, 2020 (Actual)
Study Completion Date
May 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Medical University of South Carolina, VA Connecticut Healthcare System, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm Malignant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual care group will receive standard of care management from their Oncologist.
Intervention Type
Behavioral
Intervention Name(s)
Prescribed Activity
Intervention Description
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
Primary Outcome Measure Information:
Title
Overall Step Count
Description
Participants will wear a Fitbit wrist band that will record step count.
Time Frame
baseline to 12 weeks
Title
Number of Weeks Participants Adhered to Step Count Recommendations
Description
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.
Time Frame
baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea.
Time Frame
change from pre- to post-intervention (week 12)
Title
Depression
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Global Health Status
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Physical Functioning
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Role Functioning
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Emotional Functioning
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Fatigue
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Cognitive Functioning
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Nausea/Vomiting
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Pain
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Social Functioning
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Dyspnea
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Insomnia
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Appetite Loss
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Constipation
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Diarrhea
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Quality of Life: Financial Difficulties
Description
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.
Time Frame
change from pre- to post-intervention (week 12)
Title
Moderate Aerobic Exercise
Description
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Time Frame
baseline to 12 weeks
Title
Vigorous Aerobic Exercise
Description
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Time Frame
baseline to 12 weeks
Title
Change in C-reactive Protein (CRP)
Description
The investigators will obtain serum CRP, a marker of inflammation.
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Leptin Level
Description
The investigators will obtain serum leptin, a marker of glucose control. .
Time Frame
change from pre- to post-intervention (week 12)
Title
Change in Insulin Level
Description
The investigators will obtain serum insulin level, a measure of glucose control.
Time Frame
change from pre- to post-intervention (week 12)
Title
Programmed Death - Ligand
Description
The investigators will collect soluble PD- L1, a novel cancer marker.
Time Frame
change from pre- to post-intervention (week 12)
Title
Programmed Cell Death (PD-1)
Description
The investigators will collect soluble PD- 1, a novel cancer marker.
Time Frame
change from pre- to post-intervention (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Bade, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33794808
Citation
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.
Results Reference
derived

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

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