What this study is
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.
What's being tested
- Educational Intervention
Intervention · OTHER
Attend telephone-based coaching sessions
- Educational Intervention
Intervention · OTHER
Receive written educational materials on physical activity and standard preoperative care
- Exercise Intervention
Intervention · OTHER
Receive a personalized physical activity program, set fitness goals
- Medical Device Usage and Evaluation
Intervention · OTHER
Wear activity monitor
- Physical Performance Testing
Intervention · OTHER
- Quality-of-Life Assessment
Intervention · OTHER
- Questionnaire Administration
Intervention · OTHER
All of Physical Performance Testing, Quality-of-Life Assessment, Questionnaire Administration
Ancillary studies
Study details
- Official title
- SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
- Sponsor
- City of Hope Medical Center
- Conditions
- Lung Carcinoma
- Enrolling
- 382 people
- Starts
- 2023-12-05
- Est. completion
- 2028-05-16
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (16)
16 openUniversity of California
Davis, California, United States
- Lisa Brown, MD · Contact916-734-3861lmbrown@ucdavis.edu
- Lisa Brown, MD · Principal investigator
RecruitingCity of Hope Medical Center
Duarte, California, United States
- Dan Raz · Contact626-471-7100draz@coh.org
- Dan Raz · Principal investigator
RecruitingCity of Hope at Irvine Lennar
Irvine, California, United States
RecruitingStandard University
Stanford, California, United States
- Natalie Lui, MD · Contact415-378-1406natalielui@standford.edu
- Natalie Lui, MD · Principal investigator
RecruitingCity of Hope at Upland
Upland, California, United States
RecruitingYale New Haven Medical Center
New Haven, Connecticut, United States
- Justin Blasberg, MD · Contact646-251-2670justin.blasberg@yale.edu
- Justin Blasberg, MD · Principal investigator
RecruitingMoffitt Cancer Center
Tampa, Florida, United States
- Eric Toloza, MD, PhD · Contact813-745-7282eric.toloza@moffitt.org
- Eric Toloza, MD, PhD · Principal investigator
RecruitingCity of Hope at Georgia - Atlanta
Newnan, Georgia, United States
- Eldaif Shady, MD · Contact404-252-9063seldaif@coh.org
RecruitingNorthwestern University
Evanston, Illinois, United States
- Samuel Kim, MD · Contact312-694-6469samuel.kim2@nm.org
- Samuel Kim, MD · Principal investigator
RecruitingMassachusetts General Hospital (MGH) / Harvard
Boston, Massachusetts, United States
- Chi-Fu J. Yang, MD · Contact617-726-6826cjyang@mgh.harvard.edu
- Chi-Fu J. Yang, MD · Principal investigator
RecruitingLahey Hospital & Medical Center
Burlington, Massachusetts, United States
- Elliot Servais, MD · Contact781-744-3170Elliot.Servais@lahey.org
RecruitingUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
- Jacob Moremen, MD · Contact601-984-5170jmoremen@umc.edu
- Jacob Moremen, MD · Principal investigator
RecruitingDuke University
Durham, North Carolina, United States
- Betty Tong, MD · Contact919-613-4690betty.tong@duke.edu
- Betty Tong, MD · Principal investigator
RecruitingOhio State University
Columbus, Ohio, United States
- Peter Kneuertz, MD · Contact614-293-9059peter.kneuertz@osumc.edu
- Peter Kneuertz, MD · Principal investigator
RecruitingBaptist Clinical Research Institute
Memphis, Tennessee, United States
- Jane Zhao, MD · Contact901-226-1366Jane.Zhao@bmhcc.org
- Jane Zhao, MD · Principal investigator
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
- Mara Antonoff, MD · Contact612-964-6469mbantonoff@mdanderson.org
- Mara Antonoff, MD · Principal investigator
Recruiting
Study team
Sponsor
City of Hope Medical Center
Study ID 23317
Principal investigator
Dan Raz, MD
City of Hope Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.