Status:
RECRUITING
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
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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. SECONDA...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2028
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT06196008
Start Date
December 5 2023
End Date
May 16 2028
Last Update
September 16 2025
Active Locations (13)
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1
University of California
Davis, California, United States, 95616
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
Standard University
Stanford, California, United States, 94305
4
Standford University
Stanford, California, United States, 94305