Assessing Delivery Approaches for Prehabilitation Trials in Ovarian Cancer: A Pilot Feasibility Patient-Preference Trial
| Registry | NCT07609082, acronym ADAPT-OC |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: single, supportive care |
| Enrollment | 36 (Estimated) |
| Sponsor | Jordan Leitch (Other); collaborators: Kingston Health Sciences Centre, Queen's University |
| Conditions | Prehabilitation, Preoperative Aerobic Training, Preoperative Care, Ovarian Cancer, Exercise Therapy, Postoperative Outcomes |
| Interventions | Multimodal Prehabilitation Program, Educational Materials (Behavioral, other) |
| Dates | start 2026-05-14 (estimated), primary completion 2027-05-14 (estimated), completion 2027-05-14 (estimated), first posted 2026-05-27, last updated 2026-05-27 |
| Locations | 1 site in Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Prehabilitation All trials for Preoperative Aerobic Training All trials of Multimodal Prehabilitation Program All trials of Educational Materials
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| In-Person Prehabilitation | Experimental | Behavioral: Multimodal Prehabilitation Program; Other: Educational Materials | 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. |
| Remote Prehabilitation | Experimental | Behavioral: Multimodal Prehabilitation Program; Other: Educational Materials | 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. |
| Education Only | Active comparator | Other: Educational Materials | 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. |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kingston Health Sciences Centre | Kingston, Ontario | Canada |