Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Physical activity plus positive affect; Behavioral: Physical activity plus education

• Registration Number: NCT02755883
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Non-small cell lung cancer (Stage 1)

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Exclusion Criteria

1. Cognitive impairment
2. Inability to walk
3. < 12 month anticipated survival
4. enrollment in other behavioral programs
5. lack of medical approval to participate
6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
7. major psychiatric illness.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity plus positive affect	Physical activity plus positive affect	Subjects will be randomized to a physical activity goal and the positive affect component
Physical activity plus education	Physical activity plus education	Subjects will be randomized to a physical activity goal and education

Primary Outcome Measures

Name	Time	Method
Kilocalories/week assessed by 6-minute walk test	1 month to 6 months

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy- Lung (FACT-L14)	1 month to 6 months	Disease-specific quality of life
Maximal Oxygen Consumption (VO2 max)	1 month to 6 months	Pulmonary function test
Forced expiratory volume (FEV1)	1 month to 6 months	Pulmonary function test
Activity expenditure (assessed by the Fit Bit Zip accelerometer)	1 month to 6 months

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States