Physical Activity Intervention for Lung Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fox Chase Cancer Center
University of Alberta, Physical Education
Brown University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00717795
First received: July 16, 2008
Last updated: July 24, 2014
Last verified: July 2014
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physical Activity Intervention for Lung Cancer Survivors

Resource links provided by NLM:


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 ]

Enrollment: 52
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Arm 1 - Physical Activity 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. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.

  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 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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00717795     History of Changes
Other Study ID Numbers: 08-067
Study First Received: July 16, 2008
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Survivor
Physical Activity
NED
08-067

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014