Coaching or self-monitoring to improve physical function in older lung cancer surgery patients 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
This study is testing whether phone coaching or self-monitoring can help older lung cancer surgery patients and their caregivers improve their physical function after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 382 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 16 sites (Davis, California and 15 other locations) |
| Trial ID | NCT06196008 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two approaches to enhance physical function in older adults undergoing surgery for lung cancer: telephone-based physical activity coaching and self-monitored physical activity. Participants will be randomized into one of the two groups, with the coaching group receiving personalized sessions and fitness goals before and after surgery. The primary objective is to measure changes in functional capacity using the 6-minute walk test at 30 days post-discharge, while secondary objectives include assessing various physical performance and quality of life metrics over a longer period. The study aims to address the functional declines often experienced by older adults during the surgical process.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who are scheduled for lung surgery with a diagnosis or suspicion of lung cancer.
Not a fit: Patients who are younger than 65 or those not scheduled for lung surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical function and quality of life for older adults undergoing lung cancer surgery.
How similar studies have performed: Other studies have shown success with telehealth-based exercise interventions, suggesting a promising approach for this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Exclusion Criteria: * 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)
Where this trial is running
Davis, California and 15 other locations
- University of California — Davis, California, United States (Recruiting)
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
- Standard University — Stanford, California, United States (Recruiting)
- City of Hope at Upland — Upland, California, United States (Recruiting)
- Yale New Haven Medical Center — New Haven, Connecticut, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- City of Hope at Georgia - Atlanta — Newnan, Georgia, United States (Recruiting)
- Northwestern University — Evanston, Illinois, United States (Recruiting)
- Massachusetts General Hospital (MGH) / Harvard — Boston, Massachusetts, United States (Recruiting)
- Lahey Hospital & Medical Center — Burlington, Massachusetts, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Baptist Clinical Research Institute — Memphis, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dan Raz, MD — City of Hope Medical Center
- Study coordinator: Dan Raz, MD
- Email: draz@coh.org
- Phone: 626-471-7100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.