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
- Conditions
- Lung Carcinoma
- Interventions
- Other: Educational InterventionOther: Exercise InterventionOther: Medical Device Usage and EvaluationOther: Physical Performance TestingOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT06196008
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 382
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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
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PATIENT: Agreement to wear pedometer during study duration
- If unwilling, exceptions may be granted with study primary investigator (PI) approval
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PATIENT: Age >= 65 years
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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
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PATIENT: Scheduled to undergo lung surgery for lung cancer or suspected lung cancer with curative intent (neoadjuvant therapy allowed)
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PATIENT: Adults lacking capacity to consent in the opinion of the attending surgeon will not be enrolled
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FCG: Documented informed consent of the participant and/or legally authorized representative
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FCG: Age >= 18
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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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (Written education) Physical Performance Testing Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. Arm I (Telephone-based coaching session) Exercise Intervention 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 (Written education) Medical Device Usage and Evaluation Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. Arm II (Written education) Quality-of-Life Assessment Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. Arm I (Telephone-based coaching session) Quality-of-Life Assessment 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 I (Telephone-based coaching session) Medical Device Usage and Evaluation 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 I (Telephone-based coaching session) Physical Performance Testing 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 (Written education) Educational Intervention Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. Arm I (Telephone-based coaching session) Educational Intervention 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 I (Telephone-based coaching session) Questionnaire Administration 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 (Written education) Questionnaire Administration Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
- Primary Outcome Measures
Name Time Method Objective patient functional capacity At 30 days post discharge Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
- Secondary Outcome Measures
Name Time Method Lower extremity function At 30, 60 and 180 days post discharge 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.
Postoperative complications Up to 60 days post discharge Will be compared by study arm via logistic regression.
Patient and caregiver reported physical function At 30, 60 and 180 days post discharge 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.
Patient time at home and away from the hospital Up to 60 days post discharge Will be compared by study arm by linear regression models.
Hospital readmissions Up to 60 days post discharge Will be compared by study arm via logistic regression.
Functional capacity At 60 and 180 days post discharge 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.
Patient and caregiver reported self efficacy At 30, 60, and 180 days post discharge 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.
Patient reported quality of life At 30, 60 and 180 days post discharge 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.
Caregiver reported quality of life At 30, 60 and 180 days post discharge 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.
Trial Locations
- Locations (13)
Standard University
🇺🇸Standford, California, United States
University of California
🇺🇸Davis, California, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Standford University
🇺🇸Stanford, California, United States
Yale New Haven Medical Center
🇺🇸New Haven, Connecticut, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Massachusetts General Hospital (MGH) / Harvard
🇺🇸Boston, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Duke University
🇺🇸Durham, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States