Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients
Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
Duarte, California, 미국, 91010
- City of Hope Medical Center
-
연락하다:
- Jessica Cheng
- 전화번호: 626-218-4673
- 이메일: jescheng@coh.org
-
Irvine, California, 미국, 92618
- City of Hope at Irvine Lennar
-
연락하다:
- Jessica Cheng
- 전화번호: 949-759-2863
- 이메일: jescheng@coh.org
-
수석 연구원:
- Jessica Cheng
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- PATIENT: Documented informed consent of the participant
- PATIENT: Willingness to comply with a physiatry consultation, start a tailored training program, and follow-up assessments
- PATIENT: Age: ≥ 18 years
- PATIENT: Able to read and write in English
- PATIENT: A diagnosis of stage III-IVA gynecologic cancer planned for NST
- PATIENT: Plan to start NST at City of Hope Orange County
- HEALTHCARE TEAM: Documented informed consent of the participant
- HEALTHCARE TEAM: Willingness to complete the Healthcare Worker Survey
- HEALTHCARE TEAM: ≥ 18 years old
- HEALTHCARE TEAM: Physicians, advanced practice providers, nurses, medical assistants, rehabilitation therapists, social workers, dietitians, mental health professionals, and other clinical staff who interact with study participants in the course of routine care
Exclusion Criteria:
- PATIENT: Current or planned cancer treatment for a second cancer
- PATIENT: Clinically significant uncontrolled illness limiting participation with the research intervention and assessments
- PATIENT: Stage IVB cancer with distant metastases
- PATIENT: Other active malignancy
- PATIENT: Pregnant or breastfeeding
- PATIENT: Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- PATIENT: Meeting or exceeding exercise guidelines over the last one month based on the responses from the Godin-Shephard Leisure Time Physical Activity Questionnaire (GSLTPAQ)
- PATIENT: Started second cycle before the physiatry consult
- PATIENT: Inability to independently follow instructions for study assessments for any reason such as mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry. (These patients may not be able to cooperate with the prehabilitation interventions or with the data collection process.)
- PATIENT: Unable to independently answer questionnaires in English
- HEALTHCARE TEAM: Healthcare workers who do not interact with study participants and therefore cannot provide relevant feedback
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Supportive care (physiatry-led prehabilitation)
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.
|
보조 연구
보조 연구
Receive written prehabilitation education materials
다른 이름들:
Follow and meet prehabilitation goals
Receive tailored multidisciplinary referrals
다른 이름들:
Attend cancer physiatry consultation
다른 이름들:
Receive resistance bands, nutritional guidance sources, and tips and resources
다른 이름들:
Receive starter prescription
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant completion and adherence to the prescribed training program (Feasibility)
기간: Up to 28 days immediately prior to surgery
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Enrollment rate (Feasibility)
기간: Up to 1 year
|
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)
기간: From Baseline up to 21-35 days post-surgery
|
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)
기간: From Baseline up to 21-35 days post-surgery
|
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)
기간: From Baseline up to 21-35 days post-surgery
|
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)
기간: From Baseline up to 21-35 days post-surgery
|
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
기간: From Baseline up to 21-35 days post-surgery
|
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
기간: From Baseline up to 21-35 days post-surgery
|
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
기간: From Baseline to 21-35 days post-surgery
|
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
기간: From Baseline to 21-35 days post-surgery
|
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)
기간: From Baseline to 21-35 days post-surgery
|
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
기간: Baseline to 21-35 days post-surgery
|
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
기간: Baseline to 21-35 days post-surgery
|
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
기간: Baseline to 21-35 days post-surgery
|
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
기간: Baseline to 21-35 days post-surgery
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jessica Cheng, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24765 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-03209 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
설문조사 관리에 대한 임상 시험
-
Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음
-
Fondazione Poliambulanza Istituto Ospedaliero알려지지 않은
-
Children's Mercy Hospital Kansas City완전한
-
Rio de Janeiro State UniversityUniversidade Federal Fluminense; Rio de Janeiro State Research Supporting Foundation (FAPERJ)모병