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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJordan Leitch

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Surgery scheduled <3 weeks from booking

Receiving neoadjuvant chemotherapy

Positive contraindications to exercise on the CSEP Get Active Questionnaire

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal Prehabilitation Program

    Behavioral

    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.

  • Educational Materials

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: In-Person PrehabilitationExperimental treatment 2 interventions
Group B: Remote PrehabilitationExperimental treatment 2 interventions
Group C: Education OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Behavioural adherence to exercise target (≥10 MET-hours/week)

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%)

Time frame
Enrolment to preoperative assessment (3-6 weeks)
2

Patient preference for delivery model

Proportion selecting in-person, remote, or education-only arms. Qualitative exploration of reasons for preference.

Time frame
Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.

Secondary outcomes

1

Recruitment rate

Proportion of eligible patients approached who consent and enroll.

Time frame
12-month recruitment period
2

Retention rate

Proportion of enrolled participants completing all study assessments through 4-week postoperative follow-up.

Time frame
Enrolment to 4-week postoperative assessment
3

Intervention adherence

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.

Time frame
Enrolment to preoperative assessment
4

Adverse events

Any medical events potentially related to exercise, nutrition, or behavioural intervention components.

Time frame
Enrolment to 4-week postoperative assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jordan Leitch

Lead sponsor

Queen's University

Sponsor institution

Kingston Health Sciences Centre

Collaborator

Queen's University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: