Lung CarcinomaNCT06196008
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
A study testing Educational Intervention, Exercise Intervention and Medical Device Usage and Evaluation in people with Lung Carcinoma, run by City of Hope Medical Center at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention, Exercise Intervention and Medical Device Usage and Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 16 sitesUnited States
- Study dates
- 5 Dec 2023to 16 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Massachusetts General Hospital (MGH) / Harvard
Boston, Massachusetts, 02114
Chi-Fu J. Yang, MD, 617-726-6826, cjyang@mgh.harvard.edu
Chi-Fu J. Yang, MD
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Elliot Servais, MD, 781-744-3170, Elliot.Servais@lahey.org
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Peter Kneuertz, MD, 614-293-9059, peter.kneuertz@osumc.edu
Peter Kneuertz, MD
- Recruiting
University of California
Davis, California, 95616
Lisa Brown, MD, 916-734-3861, lmbrown@ucdavis.edu
Lisa Brown, MD
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Dan Raz, 626-471-7100, draz@coh.org
Dan Raz
- Recruiting
Duke University
Durham, North Carolina, 27710
Betty Tong, MD, 919-613-4690, betty.tong@duke.edu
Betty Tong, MD
- Recruiting
Northwestern University
Evanston, Illinois, 60208
Samuel Kim, MD, 312-694-6469, samuel.kim2@nm.org
Samuel Kim, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Mara Antonoff, MD, 612-964-6469, mbantonoff@mdanderson.org
Mara Antonoff, MD
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jacob Moremen, MD, 601-984-5170, jmoremen@umc.edu
Jacob Moremen, MD
- Recruiting
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
Jane Zhao, MD, 901-226-1366, Jane.Zhao@bmhcc.org
Jane Zhao, MD
- Recruiting
Yale New Haven Medical Center
New Haven, Connecticut, 06510
Justin Blasberg, MD, 646-251-2670, justin.blasberg@yale.edu
Justin Blasberg, MD
- Recruiting
City of Hope at Georgia - Atlanta
Newnan, Georgia, 30265
Eldaif Shady, MD, 404-252-9063, seldaif@coh.org
- Recruiting
Standard University
Stanford, California, 94305
Natalie Lui, MD, 415-378-1406, natalielui@standford.edu
Natalie Lui, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Eric Toloza, MD, PhD, 813-745-7282, eric.toloza@moffitt.org
Eric Toloza, MD, PhD
- Recruiting
City of Hope at Upland
Upland, California, 91786
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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
- Lung Carcinoma
- Being tested
- Educational Intervention, Exercise Intervention, Medical Device Usage and Evaluation, Physical Performance Testing, Quality-of-Life Assessment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend telephone-based coaching sessions
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive written educational materials on physical activity and standard preoperative care
Exercise InterventionOther
Receive a personalized physical activity program, set fitness goals
Medical Device Usage and EvaluationOther
Wear activity monitor
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Telephone-based coaching session) | Experimental | 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. Receives: Other: Educational Intervention; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (Written education) | Active comparator | Patients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. Receives: Other: Educational Intervention; Other: Medical Device Usage and Evaluation; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective patient functional capacity
Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model.
Measured: At 30 days post discharge
Secondary outcomes (9)
Functional capacity
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.
Measured: At 60 and 180 days post discharge
Lower extremity function
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.
Measured: At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
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.
Measured: At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
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.
Measured: At 30, 60 and 180 days post discharge
Patient reported quality of life
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.
Measured: At 30, 60 and 180 days post discharge
Caregiver reported quality of life
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.
Measured: At 30, 60 and 180 days post discharge
Patient time at home and away from the hospital
Will be compared by study arm by linear regression models.
Measured: Up to 60 days post discharge
Hospital readmissions
Will be compared by study arm via logistic regression.
Measured: Up to 60 days post discharge
Postoperative complications
Will be compared by study arm via logistic regression.
Measured: Up to 60 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start5 Dec 2023
- Primary completion16 May 2028 (estimated)
- Study completion16 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dan Raz, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196008
- Sponsor's protocol ID
- 23317
- Other IDs
- NCI-2023-09810, 23317, P30CA033572
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39118035
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SR2204: A Randomized Phase III Trial of a Perioperative Physical Activity Intervention in Older Adults With Lung Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06196008
- Acronym / sponsor ID
- 23317
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 16 May 2028 (estimated)
- Study completion
- 16 May 2028 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Telephone-based coaching session) | Experimental | Other: Educational Intervention, Other: Exercise Intervention, Other: Medical Device Usage and Evaluation, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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) | Active comparator | Other: Educational Intervention, Other: Medical Device Usage and Evaluation, Other: Physical Performance Testing, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive written educational materials on physical activity and cancer survivorship. Patients and FCGs also wear an activity monitor throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- PATIENT: Age >= 65 years
- PATIENT: Ability to read and understand English or Spanish and willingness to complete participant-reported outcomes and assessments
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend telephone-based coaching sessions | Other | Arm I (Telephone-based coaching session) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive written educational materials on physical activity and standard preoperative care | Other | Arm II (Written education) |
| Exercise InterventionReceive a personalized physical activity program, set fitness goals | Other | Arm I (Telephone-based coaching session) |
| Medical Device Usage and EvaluationWear activity monitor | Other | Arm I (Telephone-based coaching session), Arm II (Written education) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Arm I (Telephone-based coaching session), Arm II (Written education) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (Telephone-based coaching session), Arm II (Written education) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Telephone-based coaching session), Arm II (Written education) |
Primary outcome
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.
9 secondary outcomes
Functional capacity
Time frame: At 60 and 180 days post discharge
Lower extremity function
Time frame: At 30, 60 and 180 days post discharge
Patient and caregiver reported self efficacy
Time frame: At 30, 60, and 180 days post discharge
Patient and caregiver reported physical function
Time frame: At 30, 60 and 180 days post discharge
Patient reported quality of life
Time frame: At 30, 60 and 180 days post discharge
Caregiver reported quality of life
Time frame: 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
Hospital readmissions
Time frame: Up to 60 days post discharge
Postoperative complications
Time frame: Up to 60 days post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 39118035Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Raz, MD principal investigator
City of Hope Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Exercise Intervention and Medical Device Usage and Evaluation in people with Lung Carcinoma, run by City of Hope Medical Center at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Raz, MD (626-471-7100, draz@coh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective patient functional capacity (time frame: At 30 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.