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Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Ovarian Cancer Surgery (ADAPT-OC)

19 mai 2026 mis à jour par: Jordan Leitch

Assessing Delivery Approaches for Prehabilitation Trials in Ovarian Cancer: A Pilot Feasibility Patient-Preference Trial

The goal of this clinical trial is to learn whether high-dose multimodal prehabilitation, delivered either in person or remotely with coaching and web application support, is feasible and acceptable for women preparing for ovarian cancer surgery. It will also examine which delivery model patients prefer and the factors influencing patient preferences.

The main questions ADAPT-OC aims to answer are:

  1. Can participants achieve the prescribed aerobic exercise target of at least 10 MET-hours per week before surgery?
  2. Do patients prefer in-person prehabilitation, remote prehabilitation, or education-only care, and what factors influence that preference?

The researchers will compare in-person prehabilitation, remote prehabilitation, and education-only care to see which delivery approach is most feasible, acceptable, and practical for patients with suspected ovarian cancer.

Participants will:

  • Choose their preferred study group, or be randomly assigned if they have no preference
  • Complete physical assessments, questionnaires, and interviews at baseline, 1-3 days before surgery, and 4 weeks after surgery
  • If assigned to a prehabilitation group, complete aerobic exercise, protein supplementation, and daily breathing exercises before surgery
  • Attend weekly coaching sessions with a trained prehabilitation coach
  • Use the KingstonPrehab web application to track exercise, nutrition, breathing practice, and progress toward activity goals

Aperçu de l'étude

Description détaillée

Assessing Delivery Approaches for Prehabilitation Trials in Ovarian Cancer (ADAPT-OC) is a single-centre, three-arm, partially randomized patient-preference pilot feasibility trial designed to evaluate whether high-dose multimodal prehabilitation can be delivered with sufficient adherence in women preparing for ovarian cancer surgery. The study compares in-person prehabilitation, remote prehabilitation, and education-only to determine which delivery approach is most feasible and acceptable among women undergoing primary cytoreductive surgery for an ovarian mass. Findings from this pilot study will inform future work.

Postoperative complications remain common after gynecologic oncology surgery, and ovarian cancer surgery is associated with particularly high rates of morbidity. Low cardiorespiratory fitness, reduced muscle mass, poor nutritional status, and psychological distress contribute to reduced physiological reserve and increase vulnerability to surgical stress. Prehabilitation aims to improve physiological reserve before surgery through exercise, nutritional optimization, and psychological support. Although previous studies suggest prehabilitation may improve recovery and postoperative outcomes, recent trials have reported inconsistent findings, likely due to low exercise dose and poor adherence. Evidence suggests that achieving sufficient aerobic exercise volume is critical for improving cardiorespiratory fitness and surgical outcomes.

Barriers such as travel, scheduling, financial burden, fatigue, and limited access to hospital-based programs often reduce participation in traditional in-person prehabilitation. Remote delivery models may improve access, particularly for patients living outside major centres, but maintaining adherence without supervision remains challenging. Behaviour change strategies, including goal setting, self-monitoring, action planning, and personalized coaching, may improve adherence when integrated into digitally supported home-based programs. However, the feasibility of delivering a high-dose, application-supported, and behaviour change informed prehabilitation intervention in ovarian cancer patients is unknown.

Participants will be women aged 18 years or older undergoing surgery for an ovarian mass suspicious for malignancy at Kingston Health Sciences Centre, with at least 3 weeks until surgery. Following baseline assessments and informed consent, participants will be presented with 3 study options: in-person prehabilitation, remote prehabilitation, or education-only. Participants with a strong preference may choose their preferred group, while those without a preference will be randomized equally to one of the groups.

The intervention includes progressive aerobic exercise targeting at least 10 MET-hours per week above baseline, nutritional support through protein supplementation and dietary guidance, daily box breathing for stress management, weekly one-on-one coaching sessions, and use of the KingstonPrehab web application for tracking exercise, nutrition, breathing practice, and progress toward individualized goals. Coaching is guided by the Capability, Opportunity, Motivation-Behaviour (COM-B) framework and delivered by kinesiology-educated coaches. Participants in the control arm will receive standardized educational materials on prehabilitation concepts and postoperative recovery optimization only.

The primary feasibility outcomes are adherence to the aerobic exercise prescription, defined as achieving at least 10 MET-hours per week, and patient preference for program delivery model. Secondary outcomes include recruitment, retention, adherence to intervention components, application engagement, and adverse events. Exploratory clinical outcomes include body composition, functional capacity, quality of life, nutritional status, anxiety and depression, disability, postoperative complications, hospital length of stay, and time to chemotherapy.

Semi-structured interviews conducted at baseline and preoperative assessments will explore participant expectations, experiences, barriers, facilitators, and perceptions of program structure, coaching strategies, and delivery format. These findings will support refinement of the intervention and future trial design.

Analyses will focus primarily on feasibility outcomes using descriptive statistics and predefined progression criteria based on recruitment, retention, and adherence. Qualitative data will be analyzed using thematic analysis to identify key barriers and facilitators influencing participation and intervention success.

The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and all applicable Canadian regulations. Results from this pilot trial will inform the development of a larger effectiveness trial and help determine whether remote and in-person high-dose prehabilitation can be implemented successfully in women undergoing ovarian cancer surgery.

Type d'étude

Interventionnel

Inscription (Estimé)

36

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.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7

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

Non

La description

Inclusion Criteria:

  • Female
  • Aged ≥18 years
  • Scheduled for cytoreductive surgery for an ovarian mass suspected or confirmed of cancer
  • Surgery planned ≥3 weeks from time of booking
  • No contraindications to exercise on the CSEP Get Active Questionnaire
  • Able to provide written informed consent
  • Able to understand and communicate in English

Exclusion Criteria:

  • Pregnancy
  • Surgery scheduled <3 weeks from booking
  • Receiving neoadjuvant chemotherapy
  • Positive contraindications to exercise on the CSEP Get Active Questionnaire
  • End-stage or advanced renal disease limiting safe protein supplementation
  • Malnutrition as assessed by a registered dietician

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: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: In-Person Prehabilitation
Participants will complete a multimodal prehabilitation program delivered in-person at the School of Kinesiology and Health Studies. The intervention consists of supervised aerobic exercise (≥10 MET-hours/week above baseline), daily protein supplementation, daily box breathing, weekly one-on-one behavioural coaching, use of the KingstonPrehab web application, and standardized educational materials.
The multimodal prehabilitation program consists of progressive aerobic exercise targeting at least 10 MET-hours/week above baseline via 3-5 sessions per week, daily protein supplementation (BOOST Carb Smart; Nestlé Canada Inc.; North York, Ontario, Canada), daily box breathing for stress management, weekly one-on-one behavioural coaching sessions with a trained prehabilitation coach, and use of the KingstonPrehab web application for self-monitoring and progress tracking. Aerobic exercise sessions will be supervised on site. This intervention is delivered either in-person or remotely depending on study arm allocation.
Participants receive standardized educational materials describing the principles of prehabilitation, including aerobic exercise, resistance exercise, nutrition focusing on perioperative protein intake, and stress management strategies. Participants will also receive a postoperative recovery handbook adapted from the Montreal General Hospital Prehabilitation Clinic that provides guidance on nutrition, pain and constipation management, mobilization, in-hospital exercise, and a progressive return-to-activity plan for the first 8 weeks after surgery.
Expérimental: Remote Prehabilitation
Participants will complete the same multimodal prehabilitation program as the in-person arm, but remotely at home or in community facilities. The intervention consists of independent aerobic exercise (≥10 MET-hours/week above baseline), daily protein supplementation, daily box breathing, weekly virtual one-on-one behavioural coaching, use of the KingstonPrehab web application, and standardized educational materials.
The multimodal prehabilitation program consists of progressive aerobic exercise targeting at least 10 MET-hours/week above baseline via 3-5 sessions per week, daily protein supplementation (BOOST Carb Smart; Nestlé Canada Inc.; North York, Ontario, Canada), daily box breathing for stress management, weekly one-on-one behavioural coaching sessions with a trained prehabilitation coach, and use of the KingstonPrehab web application for self-monitoring and progress tracking. Aerobic exercise sessions will be supervised on site. This intervention is delivered either in-person or remotely depending on study arm allocation.
Participants receive standardized educational materials describing the principles of prehabilitation, including aerobic exercise, resistance exercise, nutrition focusing on perioperative protein intake, and stress management strategies. Participants will also receive a postoperative recovery handbook adapted from the Montreal General Hospital Prehabilitation Clinic that provides guidance on nutrition, pain and constipation management, mobilization, in-hospital exercise, and a progressive return-to-activity plan for the first 8 weeks after surgery.
Comparateur actif: Education Only
Participants will receive standardized educational materials describing prehabilitation, including aerobic exercise, resistance training, nutrition, and stress management strategies. They will continue with usual preoperative care provided by their healthcare team and will not receive coaching sessions, protein supplementation, or access to the KingstonPrehab web application.
Participants receive standardized educational materials describing the principles of prehabilitation, including aerobic exercise, resistance exercise, nutrition focusing on perioperative protein intake, and stress management strategies. Participants will also receive a postoperative recovery handbook adapted from the Montreal General Hospital Prehabilitation Clinic that provides guidance on nutrition, pain and constipation management, mobilization, in-hospital exercise, and a progressive return-to-activity plan for the first 8 weeks after surgery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Behavioural adherence to exercise target (≥10 MET-hours/week)
Délai: Enrolment to preoperative assessment (3-6 weeks)
Individual aerobic exercise adherence, expressed as a percentage of the minimum prescribed target (≥10 MET-hours/week above baseline), capped at 100%. (Go ≥75%, Amend 61-74%, Stop <60%)
Enrolment to preoperative assessment (3-6 weeks)
Patient preference for delivery model
Délai: Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.
Proportion selecting in-person, remote, or education-only arms. Qualitative exploration of reasons for preference.
Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Recruitment rate
Délai: 12-month recruitment period
Proportion of eligible patients approached who consent and enroll.
12-month recruitment period
Retention rate
Délai: Enrolment to 4-week postoperative assessment
Proportion of enrolled participants completing all study assessments through 4-week postoperative follow-up.
Enrolment to 4-week postoperative assessment
Intervention adherence
Délai: Enrolment to preoperative assessment
Separate adherence to aerobic exercise, protein supplementation, breathing practice, and coaching attendance. Expressed as a percentage of completed / prescribed. Summarized individually per component, and as composite score.
Enrolment to preoperative assessment
Adverse events
Délai: Enrolment to 4-week postoperative assessment
Any medical events potentially related to exercise, nutrition, or behavioural intervention components.
Enrolment to 4-week postoperative assessment
Semi-structured interviews
Délai: Enrolment and 1-3 days preoperative
Qualitative assessment of acceptability, barriers, facilitators, coaching experience, and web application usability; analysed via thematic analysis.
Enrolment and 1-3 days preoperative
Cardiorespiratory Fitness (VO2max)
Délai: Baseline, preoperative, 4 weeks postoperative
Incremental shuttle walk test (ISWT): total distance (m) until volitional exhaustion or failure to complete shuttle in time is used to compute an estimated VO2max (ml/kg/min). Higher number indicates greater cardiorespiratory fitness.
Baseline, preoperative, 4 weeks postoperative
Handgrip strength (kg)
Délai: Baseline, preoperative, 4 weeks postoperative

Handheld dynamometer: average of 3 trials in dominant hand.

Higher number indicates greater forearm strength.

Baseline, preoperative, 4 weeks postoperative
30sec Sit to Stand
Délai: Baseline, preoperative, 4 weeks postoperative

Completed repetitions of unassisted sitting to and standing up from a chair.

Higher repetitions indicate greater lower body strength capacity.

Baseline, preoperative, 4 weeks postoperative
30sec Arm Curl
Délai: Baseline, preoperative, 4 weeks postoperative
Maximum repetitions of seated arm curls using 5lb dumbbell in dominant hand. Higher number indicates greater upper body strength capacity.
Baseline, preoperative, 4 weeks postoperative
BMI (kg/m^2)
Délai: Baseline, preoperative, 4 weeks postoperative
Height (m) and weight (kg) used to compute BMI (kg/m^2)
Baseline, preoperative, 4 weeks postoperative
Body Fat Percentage
Délai: Baseline, preoperative, 4 weeks postoperative
Bioelectrical impedance (Tanita Segmental Body Composition Analyser Model BC-418; Tanita Corp of America, Arlington Heights, Illinois, USA) used to estimate body fat percentage.
Baseline, preoperative, 4 weeks postoperative
Quality of Life (FACT-G)
Délai: Baseline, preoperative, 4 weeks postoperative
Functional Assessment of Cancer Therapy, General (FACT-G) to measure cancer-related quality of life across physical, social/family, emotional, and functional well-being. Range: 0-108, higher scores indicate better quality of life.
Baseline, preoperative, 4 weeks postoperative
Nutritional Status (PG-SGA SF)
Délai: Baseline, preoperative, 4 weeks postoperative
Patient-Generated Subjective Global Assessment, Short Form (PG-SGA SF) to measure nutritional status and nutrition-related symptom burden. Range: 0-36, higher scores indicate worse nutritional status and greater risk of malnutrition.
Baseline, preoperative, 4 weeks postoperative
Anxiety & Depression (HADS)
Délai: Baseline, preoperative, 4 weeks postoperative
Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression. Total range: 0-42, higher scores indicate worse psychological distress.
Baseline, preoperative, 4 weeks postoperative
Functional Impairment / Disability (WHODAS 2.0)
Délai: Baseline, preoperative, 4 weeks postoperative
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) to measure disability and functional impairment across daily life domains. Range: 0-180, higher scores indicate greater disability.
Baseline, preoperative, 4 weeks postoperative

Collaborateurs et enquêteurs

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

Parrainer

Les enquêteurs

  • Chercheur principal: Jordan Leitch, MSc, MD, FRCPC, Queen's University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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)

14 mai 2026

Achèvement primaire (Estimé)

14 mai 2027

Achèvement de l'étude (Estimé)

14 mai 2027

Dates d'inscription aux études

Première soumission

7 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

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

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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Essais cliniques sur Multimodal Prehabilitation Program

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