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
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
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
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Duarte, California, États-Unis, 91010
- City of Hope Medical Center
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Contact:
- Jessica Cheng
- Numéro de téléphone: 626-218-4673
- E-mail: jescheng@coh.org
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Irvine, California, États-Unis, 92618
- City of Hope at Irvine Lennar
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Contact:
- Jessica Cheng
- Numéro de téléphone: 949-759-2863
- E-mail: jescheng@coh.org
-
Chercheur principal:
- Jessica Cheng
-
-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
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
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)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / 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.
|
Etudes annexes
Etudes annexes
Receive written prehabilitation education materials
Autres noms:
Follow and meet prehabilitation goals
Receive tailored multidisciplinary referrals
Autres noms:
Attend cancer physiatry consultation
Autres noms:
Receive resistance bands, nutritional guidance sources, and tips and resources
Autres noms:
Receive starter prescription
|
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
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Mesures de résultats secondaires
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
Parrainer
Parrainer
Collaborateurs
Collaborateurs
Les enquêteurs
Les enquêteurs
- Chercheur principal: Jessica Cheng, City of Hope Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Pratique professionnelle
- Organisation et administration
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Techniques d'investigation
- Méthodes épidémiologiques
- Thérapeutique
- Collecte de données
- Mécanismes d'évaluation des soins de santé
- Qualité des soins de santé
- Santé publique
- Environnement et santé publique
- Soins aux patients
- Services de santé
- Conseils de soins de santé
- Services de santé infantile
- Services de santé communautaire
- Services de santé préventifs
- Facteurs socioéconomiques
- Caractéristiques de la population
- Suivi
- Continuité des soins aux patients
- Méthodes
- Entretiens comme sujet
- Soins palliatifs
- Intervention précoce, éducatif
- Statut éducatif
- Réhabilitation
- Référence et consultation
- Objectifs organisationnels
Autres numéros d'identification d'étude
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
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