Back to resultsStrides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity plus positive affect
Physical activity plus education
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring Physical activity, non-small lung cancer, positive affect
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.
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical activity plus positive affect
Physical activity plus education
Arm Description
Subjects will be randomized to a physical activity goal and the positive affect component
Subjects will be randomized to a physical activity goal and education
Outcomes
Primary Outcome Measures
Kilocalories/week assessed by 6-minute walk test
Secondary Outcome Measures
Forced expiratory volume (FEV1)
Pulmonary function test
Functional Assessment of Cancer Therapy- Lung (FACT-L14)
Disease-specific quality of life
Activity expenditure (assessed by the Fit Bit Zip accelerometer)
Maximal Oxygen Consumption (VO2 max)
Pulmonary function test
Full Information
NCT ID
NCT02755883
First Posted
April 25, 2016
Last Updated
February 6, 2018
Sponsor
Weill Medical College of Cornell University
Collaborators
Lung Cancer Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02755883
Brief Title
Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Lung Cancer Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Physical activity, non-small lung cancer, positive affect
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity plus positive affect
Arm Type
Experimental
Arm Description
Subjects will be randomized to a physical activity goal and the positive affect component
Arm Title
Physical activity plus education
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to a physical activity goal and education
Intervention Type
Behavioral
Intervention Name(s)
Physical activity plus positive affect
Intervention Description
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity plus education
Intervention Description
Subjects will be randomized to a physical activity goal and will receive the educational component.
Primary Outcome Measure Information:
Title
Kilocalories/week assessed by 6-minute walk test
Time Frame
1 month to 6 months
Secondary Outcome Measure Information:
Title
Forced expiratory volume (FEV1)
Description
Pulmonary function test
Time Frame
1 month to 6 months
Title
Functional Assessment of Cancer Therapy- Lung (FACT-L14)
Description
Disease-specific quality of life
Time Frame
1 month to 6 months
Title
Activity expenditure (assessed by the Fit Bit Zip accelerometer)
Time Frame
1 month to 6 months
Title
Maximal Oxygen Consumption (VO2 max)
Description
Pulmonary function test
Time Frame
1 month to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janey Peterson, EdD, MS, RN
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
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