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Physiatry-Led Cancer Prehabilitation During Neoadjuvant Systemic Therapy to Improve Function in Stage III-IVA Gynecologic Cancer Patients

19 de mayo de 2026 actualizado por: City of Hope Medical Center

Physiatry-Led Prehabilitation During Neoadjuvant Systemic Treatment Before Surgery for Advanced Gynecological Cancer: A Pilot Feasibility Study

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

25

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Duarte, California, Estados Unidos, 91010
        • City of Hope Medical center
        • Contacto:
          • Jessica Cheng
          • Número de teléfono: 626-218-4673
          • Correo electrónico: jescheng@coh.org
      • Irvine, California, Estados Unidos, 92618
        • City of Hope at Irvine Lennar
        • Contacto:
          • Jessica Cheng
          • Número de teléfono: 949-759-2863
          • Correo electrónico: jescheng@coh.org
        • Investigador principal:
          • Jessica Cheng

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: Administración de encuestas
Estudios complementarios
Otro: Entrevista
Estudios complementarios
Otro: Educational Intervention
Receive written prehabilitation education materials
Otros nombres:
  • Educación para la Intervención
  • Intervención de la Educación
  • Intervención a través de la Educación
  • Intervención Educativa
Otro: Goal Setting
Follow and meet prehabilitation goals
Otro: Referral
Receive tailored multidisciplinary referrals
Otros nombres:
  • Referido
Procedimiento: Rehabilitation
Attend cancer physiatry consultation
Otros nombres:
  • Physical Health Services / Rehabilitation
  • rehabilitation therapy
  • Rehabilitation, Medical
Otro: Supportive Care
Receive resistance bands, nutritional guidance sources, and tips and resources
Otros nombres:
  • Terapia de apoyo
  • Manejo de síntomas
Procedimiento: Tailored Intervention
Receive starter prescription

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant completion and adherence to the prescribed training program (Feasibility)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Enrollment rate (Feasibility)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

City of Hope Medical Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Jessica Cheng, City of Hope Medical center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

13 de noviembre de 2026

Finalización primaria (Estimado)

26 de noviembre de 2027

Finalización del estudio (Estimado)

26 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

27 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 24765 (Otro identificador: City of Hope Medical Center)
  • P30CA033572 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2026-03209 (Identificador de registro: CTRP (Clinical Trial Reporting Program))

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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