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

Part of paid clinical trials in Davis, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06196008
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Educational Intervention — OTHER
    Attend telephone-based coaching sessions
  • Educational Intervention — OTHER
    Receive written educational materials on physical activity and standard preoperative care
  • Exercise Intervention — OTHER
    Receive a personalized physical activity program, set fitness goals
  • Medical Device Usage and Evaluation — OTHER
    Wear activity monitor
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Dec 5, 2023
Status verified
Mar 2026
Primary completion
May 16, 2028
Completion
May 16, 2028

Study Design

Enrollment
382 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Objective patient functional capacity [ Time Frame: At 30 days post discharge ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of CaliforniaDavisCalifornia95616
Lisa Brown, MD
916-734-3861
Lisa Brown, MD (PRINCIPAL_INVESTIGATOR)
City of Hope Medical CenterDuarteCalifornia91010
Dan Raz
626-471-7100
Dan Raz (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618-
Standard UniversityStanfordCalifornia94305
Natalie Lui, MD
415-378-1406
Natalie Lui, MD (PRINCIPAL_INVESTIGATOR)
City of Hope at UplandUplandCalifornia91786-
Yale New Haven Medical CenterNew HavenConnecticut06510
Justin Blasberg, MD
646-251-2670
Justin Blasberg, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Eric Toloza, MD, PhD
813-745-7282
Eric Toloza, MD, PhD (PRINCIPAL_INVESTIGATOR)
City of Hope at Georgia - AtlantaNewnanGeorgia30265
Eldaif Shady, MD
404-252-9063
Northwestern UniversityEvanstonIllinois60208
Samuel Kim, MD
312-694-6469
Samuel Kim, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital (MGH) / HarvardBostonMassachusetts02114
Chi-Fu J. Yang, MD
617-726-6826
Chi-Fu J. Yang, MD (PRINCIPAL_INVESTIGATOR)
Lahey Hospital & Medical CenterBurlingtonMassachusetts01805
Elliot Servais, MD
781-744-3170
University of Mississippi Medical CenterJacksonMississippi39216
Jacob Moremen, MD
601-984-5170
Jacob Moremen, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Betty Tong, MD
919-613-4690
Betty Tong, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Peter Kneuertz, MD
614-293-9059
Peter Kneuertz, MD (PRINCIPAL_INVESTIGATOR)
Baptist Clinical Research InstituteMemphisTennessee38120
Jane Zhao, MD
901-226-1366
Jane Zhao, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Mara Antonoff, MD
612-964-6469
Mara Antonoff, MD (PRINCIPAL_INVESTIGATOR)

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