Exercise Therapy, Ovarian Cancer, Postoperative Outcomes, Prehabilitation, Preoperative Aerobic Training, Preoperative Care
Conditions
Keywords
postoperative outcomes, prehabilitation, nutritional support, psychological support, exercise therapy, ovarian cancer
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALMultimodal 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 sessions will be supervised on site. This intervention is delivered either in-person or remotely depending on study arm allocation.
OTHEREducational 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-to-activity plan for the first 8 weeks after surgery.
Sponsors
Jordan Leitch
Kingston Health Sciences Centre
Queen's University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the behavioural nature of the intervention, participants and intervention deliverers are not blinded. Outcome assessors are blinded to group allocation using computer system-based masking.
Intervention model description
Single-centre, three-arm, partially randomized patient-preference design. Participants are allocated to in-person prehabilitation, remote prehabilitation, or education-only. Participants with a clear preference self-select their group; those without a preference are randomized 1:1:1 using a web-based system. Participants remain in their assigned group for the study duration.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioural adherence to exercise target (≥10 MET-hours/week) | 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%) |
| Patient preference for delivery model | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 12-month recruitment period | Proportion of eligible patients approached who consent and enroll. |
| Retention rate | Enrolment to 4-week postoperative assessment | Proportion of enrolled participants completing all study assessments through 4-week postoperative follow-up. |
| Intervention adherence | 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. |
| Adverse events | Enrolment to 4-week postoperative assessment | Any medical events potentially related to exercise, nutrition, or behavioural intervention components. |
| Semi-structured interviews | Enrolment and 1-3 days preoperative | Qualitative assessment of acceptability, barriers, facilitators, coaching experience, and web application usability; analysed via thematic analysis. |
| Cardiorespiratory Fitness (VO2max) | 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. |
| Handgrip strength (kg) | Baseline, preoperative, 4 weeks postoperative | Handheld dynamometer: average of 3 trials in dominant hand. Higher number indicates greater forearm strength. |
| 30sec Sit to Stand | 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. |
| 30sec Arm Curl | 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. |
| BMI (kg/m^2) | Baseline, preoperative, 4 weeks postoperative | Height (m) and weight (kg) used to compute BMI (kg/m\^2) |
| Body Fat Percentage | 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. |
| Quality of Life (FACT-G) | 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. |
| Nutritional Status (PG-SGA SF) | 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. |
| Anxiety & Depression (HADS) | 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. |
| Functional Impairment / Disability (WHODAS 2.0) | 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. |
Countries
Canada
Contacts
CONTACTDeborah DuMerton
CONTACTRachel Phelan
PRINCIPAL_INVESTIGATORJordan Leitch, MSc, MD, FRCPC
Queen's University
Outcome results
None listed