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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
382
Attend telephone-based coaching sessions
Receive written educational materials on physical activity and standard preoperative care
Receive a personalized physical activity program, set fitness goals
Wear activity monitor
Ancillary studies
Ancillary studies
Ancillary studies
University of California
Davis, California, United States
RECRUITINGCity of Hope Medical Center
Duarte, California, United States
RECRUITINGStandard University
Stanford, California, United States
RECRUITINGYale New Haven Medical Center
New Haven, Connecticut, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGNorthwestern University
Evanston, Illinois, United States
RECRUITINGMassachusetts General Hospital (MGH) / Harvard
Boston, Massachusetts, United States
RECRUITINGLahey Hospital & Medical Center
Burlington, Massachusetts, United States
RECRUITINGUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITING...and 4 more locations
Objective patient functional capacity
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
Time frame: At 30 days post discharge
Functional capacity
Measured by 6MWT. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 60 and 180 days post discharge
Lower extremity function
Measured by the short physical performance battery. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
Measured by patient reported outcomes measurement information system (PROMIS) self efficacy. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
Measured by PROMIS physical function. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 30, 60 and 180 days post discharge
Patient reported quality of life
Measured by Functional Assessment of Cancer Therapy -Lung for patients. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 30, 60 and 180 days post discharge
Caregiver reported quality of life
Measured by City of Hope-Quality of Life-Family Caregiver for caregivers. Will be assessed via repeated measures linear regression model with adjustment for baseline value of the outcome, stratification factors, and time point.
Time frame: At 30, 60 and 180 days post discharge
Patient time at home and away from the hospital
Will be compared by study arm by linear regression models.
Time frame: Up to 60 days post discharge
Hospital readmissions
Will be compared by study arm via logistic regression.
Time frame: Up to 60 days post discharge
Postoperative complications
Will be compared by study arm via logistic regression.
Time frame: Up to 60 days post discharge
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