- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00717795
Physical Activity Intervention for Lung Cancer Survivors
June 6, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
52
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
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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-
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
21 years and older (Adult, Older Adult)
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 at least one year 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.
Description
Inclusion Criteria:
- Diagnosis and treatment at MSKCC of primary NSCLC; and/or pulmonary carcinoid;
- At least one year 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.
FOCUS GROUP ONLY:
• Completed the Physical Activity program offered through this study (08067);
Exclusion Criteria:
Presence of one of the following medical factors at screening:
- 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 medical 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 two hours travel distance from the Center
- Insufficient English fluency to complete evaluation tools.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Arm 1 - Physical Activity intervention
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For Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline).
|
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2
Arm 2 - Wait-list control
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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.
If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
conclusion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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conclusion of the study
|
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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
|
conclusion of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
June 10, 2008
Primary Completion (Actual)
June 5, 2023
Study Completion (Actual)
June 5, 2023
Study Registration Dates
First Submitted
July 16, 2008
First Submitted That Met QC Criteria
July 17, 2008
First Posted (Estimated)
July 18, 2008
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-067
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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