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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


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).
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. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (4)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Brown University, Fox Chase Cancer Center, University of Alberta, Physical Education

Country where clinical trial is conducted

United States, 

Outcome

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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