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NCT06196008NARecruitingAccepts Healthy Volunteers

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

City of Hope Medical Center

Start Date

12/5/2023

Completion Date

5/16/2028

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.

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. SECONDARY OBJECTIVES: I. To compare the following outcomes between the two comparators: Ia. 6MWT at 60 and 180 days post discharge; Ib. Short Physical Performance Battery (SPPB) at 30, 60, and 180 days post-discharge; Ic. The following scores at 30, 60, and 180 days post-discharge: a) patient and family caregiver (FCG) reported self-efficacy; b) patient and FCG reported physical function; c) and patient and FCG quality of life (QOL); Id. Patient time at home and away from the hospital through 60 days post-discharge; Ie. Hospital readmissions rate and postoperative complications through 60 days post-discharge. EXPLORATORY OBJECTIVES: I. To explore associations between comparators, outcomes, and the following: Ia. Perioperative, image-based sarcopenia using standard-of care preoperative chest computed tomography (CT) scans; Ib. Pedometer documented daily steps; Ic. Participant demographic and clinical characteristics. OUTLINE: Patients and their FCG are randomized together to 1 of 2 arms. ARM I: 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. ARM II: Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. After completion of study intervention, patients are followed up at days 60 and 180 post-discharge.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

OTHER

Educational Intervention

OTHER

Educational Intervention

OTHER

Exercise Intervention

OTHER

Medical Device Usage and Evaluation

OTHER

Physical Performance Testing

OTHER

Quality-of-Life Assessment

OTHER

Questionnaire Administration

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Conditions

Lung Carcinoma

Locations

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