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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical activity plus positive affect

Subjects will be randomized to a physical activity goal and the positive affect component

Group Type EXPERIMENTAL

Physical activity plus positive affect

Intervention Type BEHAVIORAL

Subjects will be randomized to a physical activity goal and will receive the positive affect component.

Physical activity plus education

Subjects will be randomized to a physical activity goal and education

Group Type ACTIVE_COMPARATOR

Physical activity plus education

Intervention Type BEHAVIORAL

Subjects will be randomized to a physical activity goal and will receive the educational component.

Interventions

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Physical activity plus positive affect

Subjects will be randomized to a physical activity goal and will receive the positive affect component.

Intervention Type BEHAVIORAL

Physical activity plus education

Subjects will be randomized to a physical activity goal and will receive the educational component.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Non-small cell lung cancer (Stage 1)

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No