Lung Cancer Clinical Trial; Physical Activity Intervention for Lung Cancer Survivors

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Physical Activity Intervention for Lung Cancer Survivors
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, January 2009
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
University of Alberta, Physical Education
Brown University

Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00717795

Purpose
The purpose of this study is to learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.



Condition Intervention
Lung Cancer
Survivor
Behavioral: interview and physical activity
Behavioral: interview and wait list




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: BaseLine
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Physical Activity Intervention for Lung Cancer Survivors


Further study details as provided by Memorial Sloan-Kettering Cancer Center:


Primary Outcome Measures:
To evaluate the feasibility (acceptability, adherence, treatment integrity, retention, participant satisfaction) of implementing a physical activity intervention trial among sedentary and insufficiently active lung cancer survivors. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
Obtain preliminary data on effect of a physical activity intervention on functional ability, health-related QOL, dyspnea, fatigue, balance, strength & self-report physical activity among sedentary and insufficiently active lung cancer survivors [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]


Biospecimen Retention: None Retained


Biospecimen Description:

Estimated Enrollment: 70
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Arm 1 - PA intervention Behavioral: interview and physical activity
For Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline).
2
Arm 2 - Wait-list control Behavioral: interview and wait list
Participants in the control condition (Arm 2)will be assessed at baseline and 12 weeks post baseline (Follow-up). At this time, the PA intervention will be offered at no cost to the participants in the control condition.



Eligibility


Ages Eligible for Study: 21 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population
In total, we will recruit and enroll a random sample of 70 lung cancer survivors who are 1-5 years post thoracic surgical resection and have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any adjuvant treatment.

Criteria
Inclusion Criteria:

Diagnosis and treatment at MSKCC of primary NSCLC;
1 to 5 years post thoracic surgical resection;
Have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any cancer treatment;
Currently sedentary or insufficiently active, defined by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention as less than a total of 150 minutes of at least moderate intensity PA per week;
Able to complete a six-minute walk test (6MWT);
Able to provide informed consent.
Exclusion Criteria:

Presence of one of the following medical factors:

regular use of an ambulatory aid (cane or walker);
resting oxygen saturation less than 88%;
inability to walk due to severe arthritis or other musculoskeletal problems;
a diagnosis of unstable angina in the previous 6 weeks;
a heart attack, angioplasty or heart surgery in the previous 3 months;
current heart rate <50 or >120 at rest; current uncontrolled hypertension;
current significant valvular heart disease or decompensated congestive heart failure and
patient reported pain of any origin that would preclude participation in the proposed PA intervention
Evidence of significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention
Self-reporting of greater than 60 minutes of vigorous activity per week or 150 minutes of moderate intensity PA per week.
Patient resides at more than one hour travel distance from the Center
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717795


Contacts
Contact: Jamie Ostroff, PhD ostroffj@mskcc.org
Contact: Jack Burkhalter, PhD burkhalj@mskcc.org


Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jamie Ostroff, PhD ostroffj@mskcc.org
Contact: Jack Burkhalter, PhD burkhalj@mskcc.org
Principal Investigator: Jamie Ostroff, PhD

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Fox Chase Cancer Center
University of Alberta, Physical Education
Brown University
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center

More Information


Memorial Sloan-Kettering Cancer Center

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Jamie Ostroff, Ph.D. )
Study ID Numbers: 08-067
Study First Received: July 16, 2008
Last Updated: January 19, 2009
ClinicalTrials.gov Identifier: NCT00717795 [history]
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Survivor
Physical Activity
NED



Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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