Lung Cancer Clinical Trial
Official title:
Physical Activity Intervention for Lung Cancer Survivors
| NCT number | NCT00717795 |
| Other study ID # | 08-067 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 10, 2008 |
| Est. completion date | June 5, 2023 |
| Verified date | June 2023 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | June 5, 2023 |
| Est. primary completion date | June 5, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Brown University, Fox Chase Cancer Center, University of Alberta, Physical Education |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | conclusion of the study | ||
| Secondary | 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 | conclusion of the study | ||
| Secondary | To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout. | conclusion of the study |
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