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

19 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

25

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • City of Hope Medical Center
        • Contact:
      • Irvine, California, États-Unis, 92618
        • City of Hope at Irvine Lennar
        • Contact:
        • Chercheur principal:
          • Jessica Cheng

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Administration de l'enquête
Etudes annexes
Autre: Entretien
Etudes annexes
Autre: Educational Intervention
Receive written prehabilitation education materials
Autres noms:
  • Éducation à l'intervention
  • Intervention par l'éducation
  • Intervention, Éducatif
Autre: Goal Setting
Follow and meet prehabilitation goals
Autre: Referral
Receive tailored multidisciplinary referrals
Autres noms:
  • Référé
Procédure: Rehabilitation
Attend cancer physiatry consultation
Autres noms:
  • Physical Health Services / Rehabilitation
  • rehabilitation therapy
  • Rehabilitation, Medical
Autre: Supportive Care
Receive resistance bands, nutritional guidance sources, and tips and resources
Autres noms:
  • Thérapie de soutien
  • Gestion des symptômes
  • Thérapie, Soutien
Procédure: Tailored Intervention
Receive starter prescription

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Participant completion and adherence to the prescribed training program (Feasibility)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Enrollment rate (Feasibility)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

City of Hope Medical Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Jessica Cheng, City of Hope Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

13 novembre 2026

Achèvement primaire (Estimé)

26 novembre 2027

Achèvement de l'étude (Estimé)

26 novembre 2027

Dates d'inscription aux études

Première soumission

13 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 24765 (Autre identifiant: City of Hope Medical Center)
  • P30CA033572 (Subvention/contrat des NIH des États-Unis)
  • NCI-2026-03209 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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