Clinical trial NCT00717795: Physical Activity Intervention for Lung Cancer Survivors
Official title: Physical Activity Intervention for Lung Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Survivor
Keywords: Survivor
Physical Activity
NED
08-067
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
name: University of Alberta
name: Brown University
First posted: 2008-07-18
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: conclusion of the study
Secondary outcomes:
measure: 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
timeFrame: conclusion of the study
measure: To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References: