Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

SR2204: a Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults with Lung Cancer and Their Family Caregivers

Details

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Keywords

Lung Carcinoma, Lung Neoplasms, Educational Intervention, Exercise Intervention, Medical Device Usage and Evaluation, Physical Performance Testing, Quality-of-Life Assessment, Telephone-based coaching session

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • University of California not yet accepting patients
    Davis California 95616 United States
  • City of Hope Medical Center accepting new patients
    Duarte California 91010 United States
  • Standard University accepting new patients
    Standford California 94305 United States
  • Standford University not yet accepting patients
    Stanford California 94305 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
City of Hope Medical Center
ID
NCT06196008
Study Type
Interventional
Participants
Expecting 382 study participants
Last Updated