Recruiting

Coaching & Self Monitoring

Sponsor:

City of Hope Medical Center

Code:

NCT06196008

Conditions

Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Educational Intervention

Exercise Intervention

Medical Device Usage and Evaluation

Physical Performance Testing

Study Details

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.

Conditions

Lung Carcinoma

Study ID

NCT06196008

Start date

Dec 5, 2023

Status verified date

Mar, 2026

Completion date

May 16, 2028

Anticipated

Primary completion date

May 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

382 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Educational Intervention

Attend telephone-based coaching sessions

Educational Intervention

Receive written educational materials on physical activity and standard preoperative care

Exercise Intervention

Receive a personalized physical activity program, set fitness goals

Medical Device Usage and Evaluation

Wear activity monitor

Physical Performance Testing

Ancillary studies

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Objective patient functional capacity [ Time Frame: At 30 days post discharge ]

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

Davis, California, United States, 95616

Contacts

Principal Investigator:

Lisa Brown, MD

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Dan Raz

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Standard University

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator:

Natalie Lui, MD

City of Hope at Upland

Recruiting

Upland, California, United States, 91786

Yale New Haven Medical Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Principal Investigator:

Justin Blasberg, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Eric Toloza, MD, PhD

City of Hope at Georgia - Atlanta

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Principal Investigator:

Samuel Kim, MD

Massachusetts General Hospital (MGH) / Harvard

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Chi-Fu J. Yang, MD

Lahey Hospital & Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Principal Investigator:

Jacob Moremen, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Betty Tong, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Peter Kneuertz, MD

Baptist Clinical Research Institute

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Principal Investigator:

Jane Zhao, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Mara Antonoff, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-03-05.