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

March 3, 2026 updated by: City of Hope Medical Center

SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dan Raz, MD
  • Phone Number: 626-471-7100
  • Email: draz@coh.org

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Recruiting
        • University of California
        • Contact:
        • Principal Investigator:
          • Lisa Brown, MD
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Principal Investigator:
          • Dan Raz
        • Contact:
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
      • Stanford, California, United States, 94305
        • Recruiting
        • Standard University
        • Principal Investigator:
          • Natalie Lui, MD
        • Contact:
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope at Upland
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Medical Center
        • Contact:
        • Principal Investigator:
          • Justin Blasberg, MD
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Eric Toloza, MD, PhD
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • City of Hope at Georgia - Atlanta
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Samuel Kim, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital (MGH) / Harvard
        • Contact:
        • Principal Investigator:
          • Chi-Fu J. Yang, MD
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital & Medical Center
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Jacob Moremen, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Betty Tong, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Peter Kneuertz, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Jane Zhao, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Md Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Mara Antonoff, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Medical Device Usage and Evaluation
Wear activity monitor
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Other: Educational Intervention
Attend telephone-based coaching sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Receive written educational materials on physical activity and standard preoperative care
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Exercise Intervention
Receive a personalized physical activity program, set fitness goals
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Medical Device Usage and Evaluation
Wear activity monitor
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Other: Educational Intervention
Attend telephone-based coaching sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Receive written educational materials on physical activity and standard preoperative care
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective patient functional capacity
Time Frame: At 30 days post discharge
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
At 30 days post discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 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.
At 60 and 180 days post discharge
Lower extremity function
Time Frame: 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.
At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
Time Frame: 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.
At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
Time Frame: 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.
At 30, 60 and 180 days post discharge
Patient reported quality of life
Time Frame: 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.
At 30, 60 and 180 days post discharge
Caregiver reported quality of life
Time Frame: 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.
At 30, 60 and 180 days post discharge
Patient time at home and away from the hospital
Time Frame: Up to 60 days post discharge
Will be compared by study arm by linear regression models.
Up to 60 days post discharge
Hospital readmissions
Time Frame: Up to 60 days post discharge
Will be compared by study arm via logistic regression.
Up to 60 days post discharge
Postoperative complications
Time Frame: Up to 60 days post discharge
Will be compared by study arm via logistic regression.
Up to 60 days post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dan Raz, MD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

May 16, 2028

Study Completion (Estimated)

May 16, 2028

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23317 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2023-09810 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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