Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers
Start Date
12/5/2023
Completion Date
5/16/2028
Summary
This clinical trial compares telephone-based physical activity coaching to self monitored physical activity for improving physical function in older adults who are undergoing surgery for lung cancer and their caregivers. Lung cancer surgery in older adults is associated with functional declines and unique challenges. Performing physical activity around the time of surgery has been shown to improve functional outcomes in patients and exercise programs delivered via telehealth may improve access and convenience for patients and minimize participant burden. Telephone-based physical activity coaching may improve physical functioning for older adults with lung cancer who are undergoing surgery.
Detailed Description
PRIMARY OBJECTIVE: I. To compare changes from baseline in objective patient functional capacity as measured by 6 minute walk test (6MWT) at day 30 post-discharge between the two comparators. SECONDARY OBJECTIVES: I. To compare the following outcomes between the two comparators: Ia. 6MWT at 60 and 180 days post discharge; Ib. Short Physical Performance Battery (SPPB) at 30, 60, and 180 days post-discharge; Ic. The following scores at 30, 60, and 180 days post-discharge: a) patient and family caregiver (FCG) reported self-efficacy; b) patient and FCG reported physical function; c) and patient and FCG quality of life (QOL); Id. Patient time at home and away from the hospital through 60 days post-discharge; Ie. Hospital readmissions rate and postoperative complications through 60 days post-discharge. EXPLORATORY OBJECTIVES: I. To explore associations between comparators, outcomes, and the following: Ia. Perioperative, image-based sarcopenia using standard-of care preoperative chest computed tomography (CT) scans; Ib. Pedometer documented daily steps; Ic. Participant demographic and clinical characteristics. OUTLINE: Patients and their FCG are randomized together to 1 of 2 arms. ARM I: Patients attend telephone-based coaching sessions over 20-50 minutes once 7-14 days before standard of care surgery, and then at days 7, 14, 21, and 51 post-discharge, for a total of 5 sessions. Patients also receive a personalized physical activity program and set fitness goals. FCGs also receive coaching and serve as a walking buddy for their patient. Patients and FCGs also wear an activity monitor throughout the trial. ARM II: Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. After completion of study intervention, patients are followed up at days 60 and 180 post-discharge.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Educational Intervention
Educational Intervention
Exercise Intervention
Medical Device Usage and Evaluation
Physical Performance Testing
Quality-of-Life Assessment
Questionnaire Administration
Conditions
Locations
University of California
Davis, California 95616
United States
City of Hope Medical Center
Duarte, California 91010
United States
City of Hope at Irvine Lennar
Irvine, California 92618
United States
Standard University
Stanford, California 94305
United States
City of Hope at Upland
Upland, California 91786
United States
Yale New Haven Medical Center
New Haven, Connecticut 06510
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
City of Hope at Georgia - Atlanta
Newnan, Georgia 30265
United States
Northwestern University
Evanston, Illinois 60208
United States
Massachusetts General Hospital (MGH) / Harvard
Boston, Massachusetts 02114
United States
Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Duke University
Durham, North Carolina 27710
United States
Ohio State University
Columbus, Ohio 43210
United States
Baptist Clinical Research Institute
Memphis, Tennessee 38120
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States