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

NCT ID: NCT03352245

Last Updated: 2024-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-05-24

Brief Summary

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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

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Conditions

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Lung Neoplasm Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Prescribed Activity

Intervention Type BEHAVIORAL

Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prescribed Activity

Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 FitBitĀ® 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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

VA Connecticut Healthcare System

FED

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brett Bade, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33794808 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1P50CA196530-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000022225

Identifier Type: -

Identifier Source: org_study_id

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