Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors

Weill Medical College of Cornell University1 site in 1 country29 target enrollmentApril 2016

ConditionsLung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Weill Medical College of Cornell University
Enrollment: 29
Locations: 1
Primary Endpoint: Kilocalories/week assessed by 6-minute walk test
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months.

Detailed Description

This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational Control group, results in improved function as assessed by the 6-minute Walk Test. Our primary outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

October 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-small cell lung cancer (Stage 1)

Exclusion Criteria

•Cognitive impairment
•Inability to walk
•\< 12 month anticipated survival
•enrollment in other behavioral programs
•lack of medical approval to participate
•substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
•major psychiatric illness.

Outcomes

Primary Outcomes

Kilocalories/week assessed by 6-minute walk test

Time Frame: 1 month to 6 months

Secondary Outcomes

Functional Assessment of Cancer Therapy- Lung (FACT-L14)(1 month to 6 months)
Maximal Oxygen Consumption (VO2 max)(1 month to 6 months)
Forced expiratory volume (FEV1)(1 month to 6 months)
Activity expenditure (assessed by the Fit Bit Zip accelerometer)(1 month to 6 months)