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Completed

NCT Number: NCT02755883

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

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.

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Key information

Conditions

Lung Cancer Behavior Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity plus positive affect

Behavioral

Subjects will be randomized to a physical activity goal and will receive the positive affect component.

Physical activity plus education

Behavioral

Subjects will be randomized to a physical activity goal and will receive the educational component.

Primary outcomes

  1. Kilocalories/week assessed by 6-minute walk test

    Time frame: 1 month to 6 months

Secondary outcomes

  1. Forced expiratory volume (FEV1)

    Time frame: 1 month to 6 months

    Pulmonary function test

  2. Functional Assessment of Cancer Therapy- Lung (FACT-L14)

    Time frame: 1 month to 6 months

    Disease-specific quality of life

  3. Activity expenditure (assessed by the Fit Bit Zip accelerometer)

    Time frame: 1 month to 6 months

  4. Maximal Oxygen Consumption (VO2 max)

    Time frame: 1 month to 6 months

    Pulmonary function test

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Lung Cancer Research Foundation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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