Clinical trial NCT06196008: 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
Official title: SR2204: a Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults with Lung Cancer and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-08
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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: 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)

Primary outcomes:
measure: Objective patient functional capacity
timeFrame: At 30 days post discharge
Secondary outcomes:
measure: Functional capacity
timeFrame: At 60 and 180 days post discharge
measure: Lower extremity function
timeFrame: At 30, 60 and 180 days post discharge
measure: Patient and caregiver reported self efficacy
timeFrame: At 30, 60, and 180 days post discharge
measure: Patient and caregiver reported physical function
timeFrame: At 30, 60 and 180 days post discharge
measure: Patient reported quality of life
timeFrame: At 30, 60 and 180 days post discharge
measure: Caregiver reported quality of life
timeFrame: At 30, 60 and 180 days post discharge
measure: Patient time at home and away from the hospital
timeFrame: Up to 60 days post discharge
measure: Hospital readmissions
timeFrame: Up to 60 days post discharge
measure: Postoperative complications
timeFrame: Up to 60 days post discharge
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California
state: California
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Standford
country: United States
facility: Standard University
state: California
city: Stanford
country: United States
facility: Standford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Medical Center
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH) / Harvard
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: City of Hope Medical Center
name: Dan Raz, MD
role: PRINCIPAL_INVESTIGATOR
References: