SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
City of Hope Medical Center
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.
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 patien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * PATIENT: Documented informed consent of the participant and/or legally authorized representative * PATIENT: Agreement to allow the use of preoperative chest CT scan for exploratory analysis, if available * PATIENT: Agreement to wear pedometer during study duration * If unwilling, exceptions may be granted with study primary investigator (PI) approval * PATIENT: Age \>= 65 years * PATIENT: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments * PATIENT: Diagnosis of lung cancer or presumed lung cance…
Interventions
- OtherEducational Intervention
Attend telephone-based coaching sessions
- OtherEducational Intervention
Receive written educational materials on physical activity and standard preoperative care
- OtherExercise Intervention
Receive a personalized physical activity program, set fitness goals
- OtherMedical Device Usage and Evaluation
Wear activity monitor
- OtherPhysical Performance Testing
Ancillary studies
- OtherQuality-of-Life Assessment
Ancillary studies
- Other
Locations (16)
- University of CaliforniaDavis, California
- City of Hope Medical CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California
- Standard UniversityStanford, California
- City of Hope at UplandUpland, California
- Yale New Haven Medical CenterNew Haven, Connecticut