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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| NCI-2026-03209 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24765 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies whether physiatry-led cancer prehabilitation can be used during systemic treatment before surgery (neoadjuvant systemic treatment [NST]) to improve function in stage III-IVA gynecologic cancer patients. Treatment of gynecologic cancers presents significant challenges to physical and mental health and patients often experience many challenges following treatment including sleep disturbance, extreme tiredness, sexual dysfunction, and bowel and urinary problems. Patients who have low functioning prior to surgery often have worse outcomes following surgery; however, services to support functional shortages often start after surgery. Physiatry-led cancer prehabilitation is a strategy aimed at reducing post-treatment functional challenges by improving physical and mental function before treatment. It involves physiatry, which is a medical specialty focused on function. Physiatry involvement in prehabilitation allows for the evaluation and management of co-existing conditions, medical supervision, and the coordination of complex plans involving multiple teams. Using physiatry-led cancer prehabilitation during NST may be an effective way to improve function in stage III-IVA gynecologic cancer patients.
PRIMARY OBJECTIVES:
I. Determine feasibility based on adherence (> 70%) across the key components-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in > 70% of enrolled patients for the 28-day period immediately prior to surgery.
II. Evaluate feasibility via enrollment rate > 50% of eligible patients.
SECONDARY OBJECTIVES:
I. Evaluate physical measures: Six Minute Walk Test, Duke Activity Status Index, 30-second Sit to Stand, Short Physical Performance Battery, Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief Three Domains (3D) Profile, and body composition.
II. Assess exercise behavior measures: Godin-Shephard Leisure-Time Physical Activity Questionnaire, self-reported exercise activity and future intent, Self-Efficacy for Home Exercise Programs.
III. Evaluate malnutrition risk with Malnutrition Screening Tool. IV. Assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L).
V. Evaluate symptom burden with ESAS-FS and health-related quality of life with EQ-5D-5L.
EXPLORATORY OBJECTIVES:
I. Evaluate the impact of the tailored prehabilitation program on disease outcomes as measured by Relative Dose Intensity, pathologic complete response, Response Evaluation Criteria in Solid Tumors, and cancer antigen 125 (CA-125).
II. Evaluate the impact of the tailored prehabilitation program on cancer treatment timing by examining time from diagnosis to surgery, time from last chemotherapy cycle to surgery, time from surgery to adjuvant treatment, hospitalizations and length of stay.
III. Evaluate the impact of the tailored prehabilitation program on cancer treatment complications, measured by the incidence of chemotherapy-induced peripheral neuropathy (using Common Terminology Criteria for Adverse Events [CTCAE] 5.0) and 30-day readmission rate.
IV. Identify future program improvements via a participant feedback survey and/or interview, clinician feedback survey and/or interview, reasons for non-participation, challenges to intervention adherence, and days to consult completion.
V. Document the utilization of multidisciplinary specialty services.
OUTLINE:
Patients attend a cancer physiatry consultation over 1 hour and receive an introduction to the home-based program, a starter prescription, and written prehabilitation education materials before the start of cycle 2 of NST. Patients then follow the provided starter prescription and attempt to meet aerobic exercise, resistance exercise, nutrition, and psychospiritual goals at home during and while off NST in the absence of unacceptable toxicity. Patients also attend additional cancer physiatry consultation follow-ups at 28 days and at 28 days after surgery. Additionally, patients receive resistance bands, sources for nutritional guidance, and practical tips and resources on study and may also receive tailored multidisciplinary referrals as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (physiatry-led prehabilitation) | Experimental | Patients attend a cancer physiatry consultation over 1 hour and receive an introduction to the home-based program, a starter prescription, and written prehabilitation education materials before the start of cycle 2 of NST. Patients then follow the provided starter prescription and attempt to meet aerobic exercise, resistance exercise, nutrition, and psychospiritual goals at home during and while off NST in the absence of unacceptable toxicity. Patients also attend additional cancer physiatry consultation follow-ups at 28 days and at 28 days after surgery. Additionally, patients receive resistance bands, sources for nutritional guidance, and practical tips and resources on study and may also receive tailored multidisciplinary referrals as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive written prehabilitation education materials |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant completion and adherence to the prescribed training program (Feasibility) | Feasibility will be determined primarily by participant adherence to the prescribed training program during the 28-day period immediately prior to surgery, with the goal of > 70% adherence across each key category-exercise (aerobic and resistance), nutrition, and mind/spirit practice-in > 70% of enrolled patients. Adherence will be measured via a self-reported weekly training log that will be turned in routinely to the clinical research staff. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals). | Up to 28 days immediately prior to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate (Feasibility) | Secondarily, feasibility will be evaluated via enrollment rate > 50% of eligible patients. Feasibility assessment will include descriptive statistics such as frequencies (%), along with estimates of precision (95% confidence intervals). | Up to 1 year |
| Change in physical measures - Six Minute Walk Test (6MWT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Cheng | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Goal Setting | Other | Follow and meet prehabilitation goals |
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| Interview | Other | Ancillary studies |
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| Referral | Other | Receive tailored multidisciplinary referrals |
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| Rehabilitation | Procedure | Attend cancer physiatry consultation |
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| Supportive Care | Other | Receive resistance bands, nutritional guidance sources, and tips and resources |
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| Survey Administration | Other | Ancillary studies |
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| Tailored Intervention | Procedure | Receive starter prescription |
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This Six Minute Walk Test (6MWT) test measures the distance a patient walks in 6 minutes. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. |
| From Baseline up to 21-35 days post-surgery |
| Change in physical measures - Duke Activity Status Index (DASI) | This is a 12-question validated patient-reported outcome measure of self-reported functional capacity. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline up to 21-35 days post-surgery |
| Change in physical measures - 30-second Sit to Stand (30STS) | This is an objective measure of functional capacity and lower body functional strength assessing how many times a person can go from sitting to standing within 30 seconds. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline up to 21-35 days post-surgery |
| Change in physical measures - Short Physical Performance Battery (SPPB) | This objective assessment tool evaluates lower extremity functioning in frail older adults with good validity and reliability. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline up to 21-35 days post-surgery |
| Change in physical measures - Reported Outcomes Measurement Information System (PROMS) Cancer Function Brief 3D Profile | This is a 12-question validated patient-reported outcome measure of function in outpatient cancer rehabilitation patients. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline up to 21-35 days post-surgery |
| Change in physical measures - Body composition | Body composition measures, including but not limited to fat-free mass, fat mass, and phase angle, have been associated with cancer outcomes. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline up to 21-35 days post-surgery |
| Change in exercise behavior measures - Godin-Shephard Leisure-Time Physical Activity Questionnaire | This Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ questionnaire (estimated completion time of one minute) consists of 3 self-administered questions. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline to 21-35 days post-surgery |
| Change in exercise behavior measures - Self-reported exercise activity | Self-reported exercise activity is the average exercise dose over the 1 month prior will be reported by the participant at baseline and pre-operatively. This is a 12-question patient-reported outcome measure. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline to 21-35 days post-surgery |
| Change in exercise behavior measures - Self-Efficacy for Home Exercise Programs (SEHEPS) | Self-Efficacy for Home Exercise Programs (SEHEPS) is a 12-question patient-reported outcome measure based on the Self-Efficacy for Exercise. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | From Baseline to 21-35 days post-surgery |
| Change in malnutrition risk | Will evaluate malnutrition risk with Malnutrition Screening Tool. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | Baseline to 21-35 days post-surgery |
| Change in psychological and spiritual distress | Will assess psychological and spiritual distress with relevant measures within the Edmonton Symptom Assessment Scale- Financial and Spiritual Distress (ESAS-FS) and European Quality of Life 5 Dimensions (EQ-5D-5L). Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | Baseline to 21-35 days post-surgery |
| Change in symptom burden | Will evaluate symptom burden with ESAS-FS. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | Baseline to 21-35 days post-surgery |
| Change in health-related quality of life | Will evaluate health-related quality of life with EQ-5D-5L. Changes in the outcome measure will be analyzed using paired t-tests (or non-parametric tests if the data distributions deviate from normality). These analyses will be intended to provide preliminary estimates and effect sizes, which will inform the design of future studies. The main objective will be to detect a signal rather than to test a formal hypothesis. | Baseline to 21-35 days post-surgery |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | United States |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D009937 | Organizational Objectives |
| D007407 | Interviews as Topic |
| D012017 | Referral and Consultation |
| D012046 | Rehabilitation |
| D010166 | Palliative Care |
| 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 |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011364 | Professional Practice |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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