Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Apr 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFebruary 7, 2018
February 1, 2018
1.5 years
April 25, 2016
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kilocalories/week assessed by 6-minute walk test
1 month to 6 months
Secondary Outcomes (4)
Forced expiratory volume (FEV1)
1 month to 6 months
Functional Assessment of Cancer Therapy- Lung (FACT-L14)
1 month to 6 months
Activity expenditure (assessed by the Fit Bit Zip accelerometer)
1 month to 6 months
Maximal Oxygen Consumption (VO2 max)
1 month to 6 months
Study Arms (2)
Physical activity plus positive affect
EXPERIMENTALSubjects will be randomized to a physical activity goal and the positive affect component
Physical activity plus education
ACTIVE COMPARATORSubjects will be randomized to a physical activity goal and education
Interventions
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
Subjects will be randomized to a physical activity goal and will receive the educational component.
Eligibility Criteria
You may qualify if:
- Non-small cell lung cancer (Stage 1)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janey Peterson, EdD, MS, RN
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
April 29, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
February 7, 2018
Record last verified: 2018-02