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

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.

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)