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

February 6, 2018 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Lung Cancer Research Foundation

Investigators

  • Principal Investigator: Janey Peterson, EdD, MS, RN, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1510016644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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