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
NCT ID: NCT06196008
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
382 participants
INTERVENTIONAL
2023-12-05
2028-05-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (Telephone-based coaching session)
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.
Educational Intervention
Attend telephone-based coaching sessions
Exercise Intervention
Receive a personalized physical activity program, set fitness goals
Medical Device Usage and Evaluation
Wear activity monitor
Physical Performance Testing
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (Written education)
Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial.
Educational Intervention
Receive written educational materials on physical activity and standard preoperative care
Medical Device Usage and Evaluation
Wear activity monitor
Physical Performance Testing
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Educational Intervention
Attend telephone-based coaching sessions
Educational Intervention
Receive written educational materials on physical activity and standard preoperative care
Exercise Intervention
Receive a personalized physical activity program, set fitness goals
Medical Device Usage and Evaluation
Wear activity monitor
Physical Performance Testing
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: 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)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Dan Raz, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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University of California
Davis, California, United States
City of Hope Medical Center
Duarte, California, United States
Standard 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
Lahey Hospital & Medical Center
Burlington, 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
Baptist Clinical Research Institute
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
City of Hope at Georgia - Atlanta
Newnan, GA, Georgia
Countries
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Central Contacts
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Facility Contacts
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References
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Sun V, Guthrie KA, Arnold KB, Antonoff M, Erhunmwunsee L, Borondy-Kitts A, Johnson J, Jones L, Ramirez M, Tong BC, Moremen JR, Yang CJ, Ng T, Kim SS, Brown LM, Blasberg JD, Lui NS, Kneuertz PJ, Toloza EM, Kim JY, Raz DJ. Comparative effectiveness of perioperative physical activity in older adults with lung cancer and their family caregivers: design of a multicenter pragmatic randomized trial. BMC Cancer. 2024 Aug 8;24(1):976. doi: 10.1186/s12885-024-12660-5.
Other Identifiers
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NCI-2023-09810
Identifier Type: REGISTRY
Identifier Source: secondary_id
23317
Identifier Type: OTHER
Identifier Source: secondary_id
23317
Identifier Type: -
Identifier Source: org_study_id
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