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

  • STATUS
    Recruiting
  • End date
    May 13, 2028
  • participants needed
    382
  • sponsor
    City of Hope Medical Center
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Updated on 9 January 2024
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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.

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.

Details
Condition Lung Carcinoma
Age 18years or above
Treatment Exercise Intervention, Questionnaire Administration, Quality-of-Life Assessment, Educational intervention, Physical Performance Testing, Medical Device Usage and Evaluation
Clinical Study IdentifierNCT06196008
SponsorCity of Hope Medical Center
Last Modified on9 January 2024

Eligibility

 Yes No Not Sure

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)
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