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

Study 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.

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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Physical activity plus positive affect
* Behavioral: Physical activity plus education


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity plus positive affect<br>Subjects will be randomized to a physical activity goal and the positive affect component | Behavioral: Physical activity plus positive affect<br>* Subjects will be randomized to a physical activity goal and will receive the positive affect component.<br>|
| Active Comparator: Physical activity plus education<br>Subjects will be randomized to a physical activity goal and education | Behavioral: Physical activity plus education<br>* Subjects will be randomized to a physical activity goal and will receive the educational component.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kilocalories/week assessed by 6-minute walk test |  | 1 month to 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, non-small lung cancer, positive affect