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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09810 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23317 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend telephone-based coaching sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective patient functional capacity | Measured by the 6 minute walk test (6MWT). Analysis will be a study group comparison via linear regression model. | At 30 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 60 and 180 days post discharge |
| Lower extremity function |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Raz, MD | Contact | 626-471-7100 | draz@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Dan Raz, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Recruiting | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39118035 | Derived | 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. |
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| Educational Intervention | Other | Receive written educational materials on physical activity and standard preoperative care |
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| Exercise Intervention | Other | Receive a personalized physical activity program, set fitness goals |
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| Medical Device Usage and Evaluation | Other | Wear activity monitor |
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| Physical Performance Testing | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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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 | 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 | 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 | 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 | 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 | Will be compared by study arm by linear regression models. | Up to 60 days post discharge |
| Hospital readmissions | Will be compared by study arm via logistic regression. | Up to 60 days post discharge |
| Postoperative complications | Will be compared by study arm via logistic regression. | Up to 60 days post discharge |
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
| Standard University | Recruiting | Stanford | California | 94305 | United States |
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| City of Hope at Upland | Recruiting | Upland | California | 91786 | United States |
| Yale New Haven Medical Center | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| City of Hope at Georgia - Atlanta | Recruiting | Newnan | Georgia | 30265 | United States |
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| Northwestern University | Recruiting | Evanston | Illinois | 60208 | United States |
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| Massachusetts General Hospital (MGH) / Harvard | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Lahey Hospital & Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
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| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Baptist Clinical Research Institute | Recruiting | Memphis | Tennessee | 38120 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
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