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
SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
3 other identifiers
interventional
382
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2023
CompletedFirst Submitted
Initial submission to the registry
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 16, 2028
March 5, 2026
March 1, 2026
4.4 years
December 14, 2023
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective patient functional capacity
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
At 30 days post discharge
Secondary Outcomes (9)
Functional capacity
At 60 and 180 days post discharge
Lower extremity function
At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
At 30, 60 and 180 days post discharge
Patient reported quality of life
At 30, 60 and 180 days post discharge
- +4 more secondary outcomes
Study Arms (2)
Arm I (Telephone-based coaching session)
EXPERIMENTALPatients 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 (Written education)
ACTIVE COMPARATORPatients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
Interventions
Ancillary studies
Ancillary studies
Wear activity monitor
Attend telephone-based coaching sessions
Receive a personalized physical activity program, set fitness goals
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- PATIENT: Lung surgery is scheduled in less than 14 calendar days from the time of registration
- PATIENT: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
- FCG: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including exercise program and compliance issues related to feasibility/logistics)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (16)
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
Related Publications (1)
Sun V, Guthrie KA, Arnold KB, Antonoff M, Erhunmwunsee L, Borondy-Kitts A, Johnson J, Jones L, Ramirez M, Tong BC, Moremen JR, Yang CJ, Ng T, Kim SS, Brown LM, Blasberg JD, Lui NS, Kneuertz PJ, Toloza EM, Kim JY, Raz DJ. Comparative effectiveness of perioperative physical activity in older adults with lung cancer and their family caregivers: design of a multicenter pragmatic randomized trial. BMC Cancer. 2024 Aug 8;24(1):976. doi: 10.1186/s12885-024-12660-5.
PMID: 39118035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Raz, MD
City of Hope Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2023
First Posted
January 8, 2024
Study Start
December 5, 2023
Primary Completion (Estimated)
May 16, 2028
Study Completion (Estimated)
May 16, 2028
Last Updated
March 5, 2026
Record last verified: 2026-03