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

NCT03352245 | Completed Results

• 2 other identifiers: 20000222251P50CA196530-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm Malignant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• Dyspnea

  change from pre- to post-intervention (week 12)

• Depression

  change from pre- to post-intervention (week 12)

• Change in Quality of Life: Global Health Status

  change from pre- to post-intervention (week 12)

• Change in Quality of Life: Physical Functioning

  change from pre- to post-intervention (week 12)

• Change in Quality of Life: Role Functioning

  change from pre- to post-intervention (week 12)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Prescribed Activity BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• Medical University of South Carolina: collaborator
• VA Connecticut Healthcare System: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 33794808 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Brett Bade
• Organization: Yale University

Brett.bade@yale.edu

203 785 6670

Study Officials

• Brett Bade, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: November 26, 2018
• Primary Completion: May 24, 2020
• Study Completion: May 24, 2020
• Last Updated: February 15, 2024
• Results First Posted: May 21, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)