SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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 cancer (as determined by surgeons) in patient

• PATIENT: Scheduled to undergo lung surgery for lung cancer or suspected lung cancer with curative intent (neoadjuvant therapy allowed)

• PATIENT: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled

• FCG: Documented informed consent of the participant and/or legally authorized representative

• FCG: Age \>= 18

• FCG: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments

• FCG: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled

Locations
United States
California
University of California
NOT_YET_RECRUITING
Davis
City of Hope Medical Center
RECRUITING
Duarte
Standard University
RECRUITING
Stanford
Standford University
NOT_YET_RECRUITING
Stanford
Connecticut
Yale New Haven Medical Center
RECRUITING
New Haven
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Northwestern University
NOT_YET_RECRUITING
Evanston
Massachusetts
Massachusetts General Hospital (MGH) / Harvard
RECRUITING
Boston
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Duke University
RECRUITING
Durham
Ohio
Ohio State University
NOT_YET_RECRUITING
Columbus
Tennessee
University of Tennessee Health Science Center
RECRUITING
Memphis
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Dan Raz, MD
draz@coh.org
626-471-7100
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2028-05-16
Participants
Target number of participants: 382
Treatments
Experimental: Arm I (Telephone-based coaching session)
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.
Active_comparator: Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov