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

Active:	Yes
Cancer Type:	Lung Cancer Unknown Primary	NCT ID:	NCT06196008
Trial Phases:	Phase III	Protocol IDs:	23317 (primary) NCI-2023-09810
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	City of Hope Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT06196008

Summary

This phase III 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.

Objectives

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 5-30 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 30, 60 and 180 post-discharge.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.