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

February 13, 2024 updated by: Yale University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Step Count
Time Frame: baseline to 12 weeks
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
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.
baseline to 12 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
Moderate Aerobic Exercise
Time Frame: baseline to 12 weeks
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
baseline to 12 weeks
Vigorous Aerobic Exercise
Time Frame: baseline to 12 weeks
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
baseline to 12 weeks
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.
change from pre- to post-intervention (week 12)
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. .
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)
Programmed Death - Ligand
Time Frame: change from pre- to post-intervention (week 12)
The investigators will collect soluble PD- L1, a novel cancer marker.
change from pre- to post-intervention (week 12)
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.
change from pre- to post-intervention (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
National Cancer Institute (NCI)
VA Connecticut Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brett Bade, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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