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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755883
• Other study ID #: 1510016644
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: February 6, 2018
• Start date: April 2016
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Physical activity plus positive affect
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 will receive the educational component.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Lung Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kilocalories/week assessed by 6-minute walk test		1 month to 6 months
Secondary	Forced expiratory volume (FEV1)	Pulmonary function test	1 month to 6 months
Secondary	Functional Assessment of Cancer Therapy- Lung (FACT-L14)	Disease-specific quality of life	1 month to 6 months
Secondary	Activity expenditure (assessed by the Fit Bit Zip accelerometer)		1 month to 6 months
Secondary	Maximal Oxygen Consumption (VO2 max)	Pulmonary function test	1 month to 6 months