Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Ovarian Cancer Surgery

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Multimodal Prehabilitation Program
  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 session
• Другое Educational Materials
  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-

Первичные конечные точки

• Behavioural adherence to exercise target (≥10 MET-hours/week) [Срок оценки: Enrolment to preoperative assessment (3-6 weeks)]
• Patient preference for delivery model [Срок оценки: Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.]

Вторичные конечные точки (12)

• Recruitment rate [Срок оценки: 12-month recruitment period]
• Retention rate [Срок оценки: Enrolment to 4-week postoperative assessment]
• Intervention adherence [Срок оценки: Enrolment to preoperative assessment]
• Adverse events [Срок оценки: Enrolment to 4-week postoperative assessment]
• Semi-structured interviews [Срок оценки: Enrolment and 1-3 days preoperative]
• Cardiorespiratory Fitness (VO2max) [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• Handgrip strength (kg) [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• 30sec Sit to Stand [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• 30sec Arm Curl [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• BMI (kg/m^2) [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• Body Fat Percentage [Срок оценки: Baseline, preoperative, 4 weeks postoperative]
• Quality of Life (FACT-G) [Срок оценки: Baseline, preoperative, 4 weeks postoperative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Kingston Health Sciences Centre — Kingston

Публикации

• McIsaac DI, Kidd G, Gillis C, Branje K, Al-Bayati M, Baxi A, Grudzinski AL, Boland L, Veroniki AA, Wolfe D, Hutton B. Relative efficacy of prehabilitation interventions and their components: systematic review with network and component network meta-analyses of randomised controlled trials. BMJ. 2025 Jan 22;388:e081164. doi: 10.1136/bmj-2024-081164. PMID 39843215
• McIsaac DI, Lee S, Fergusson D, Gillis C, Khadaroo RG, Meliambro A, Muscedere J, Eskander A, Moloo H, Nelson G, Saha T, Chun R, Serrano PE, Wijeysundera DN, Taljaard M; PREPARE Trial Investigator Group; Barnes K, Boet S, Boland L, Branje K, Breau R, Bryson GL, Dhalla I, Dixon E, Dobson G, Farnand M, Forster A, Gagne S, Hladkowicz E, Holroyd-Leduc J, Huang A, Hutton J, Jacobsohn E, Joanisse J, John PMID 41335421
• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. PMID 21513547
• Watts T, Courtier N, Fry S, Gale N, Gillen E, McCutchan G, Patil M, Rees T, Roche D, Wheelwright S, Hopkinson J. Access, acceptance and adherence to cancer prehabilitation: a mixed-methods systematic review. J Cancer Surviv. 2025 Dec;19(6):1895-1923. doi: 10.1007/s11764-024-01605-3. Epub 2024 May 6. PMID 38709465
• Rose GA, Davies RG, Appadurai IR, Williams IM, Bashir M, Berg RMG, Poole DC, Bailey DM. 'Fit for surgery': the relationship between cardiorespiratory fitness and postoperative outcomes. Exp Physiol. 2022 Aug;107(8):787-799. doi: 10.1113/EP090156. Epub 2022 Jun 5. PMID 35579479
• Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecologi PMID 25535730
• Fleurent-Gregoire C, Burgess N, McIsaac DI, Chevalier S, Fiore JF Jr, Carli F, Levett D, Moore J, Grocott MP, Copeland R, Edbrooke L, Engel D, Testa GD, Denehy L, Gillis C. Towards a common definition of surgical prehabilitation: a scoping review of randomised trials. Br J Anaesth. 2024 Aug;133(2):305-315. doi: 10.1016/j.bja.2024.02.035. Epub 2024 Apr 26. PMID 38677949
• McIsaac DI, Gill M, Boland L, Hutton B, Branje K, Shaw J, Grudzinski AL, Barone N, Gillis C; Prehabilitation Knowledge Network. Prehabilitation in adult patients undergoing surgery: an umbrella review of systematic reviews. Br J Anaesth. 2022 Feb;128(2):244-257. doi: 10.1016/j.bja.2021.11.014. Epub 2021 Dec 16. PMID 34922735

Идентификаторы

NCT: NCT07609082 · ADAPT-OC Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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