RecruitingNot ApplicableNCT06196008

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


Sponsor

City of Hope Medical Center

Enrollment

382 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria13

  • 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 Criteria3

  • 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)

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

OTHERQuestionnaire Administration

Ancillary studies


Locations(16)

University of California

Davis, California, United States

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

Standard University

Stanford, California, United States

City of Hope at Upland

Upland, California, United States

Yale New Haven Medical Center

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

City of Hope at Georgia - Atlanta

Newnan, Georgia, United States

Northwestern University

Evanston, Illinois, United States

Massachusetts General Hospital (MGH) / Harvard

Boston, Massachusetts, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Duke University

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Baptist Clinical Research Institute

Memphis, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06196008


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