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

NCT07609082 | Not Yet Recruiting

• 1 other identifier: ADAPT-OC Pilot
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Prehabilitation; Preoperative Aerobic Training; Preoperative Care; Ovarian Cancer; Exercise Therapy; Postoperative Outcomes

Keywords

postoperative outcomes; prehabilitation; nutritional support; psychological support; exercise therapy; ovarian cancer

Outcome Measures

Primary Outcomes (2)

• 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%)

  Enrolment to preoperative assessment (3-6 weeks)

• Patient preference for delivery model

  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.

Secondary Outcomes (15)

• Recruitment rate

  12-month recruitment period

• Retention rate

  Enrolment to 4-week postoperative assessment

• Intervention adherence

  Enrolment to preoperative assessment

• Adverse events

  Enrolment to 4-week postoperative assessment

• Semi-structured interviews

  Enrolment and 1-3 days preoperative

Study Arms (3)

In-Person Prehabilitation

EXPERIMENTAL

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.

Behavioral: Multimodal Prehabilitation Program; Other: Educational Materials

Remote Prehabilitation

EXPERIMENTAL

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.

Behavioral: Multimodal Prehabilitation Program; Other: Educational Materials

Education Only

ACTIVE COMPARATOR

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.

Other: Educational Materials

Interventions

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.

In-Person Prehabilitation; Remote Prehabilitation

Educational Materials OTHER

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.

Education Only; In-Person Prehabilitation; Remote Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Leitch: lead
• Kingston Health Sciences Centre: collaborator
• Queen's University: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (9)

• 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 BACKGROUND

• 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, Johnson A, Johnson S, Khalil N, Kidd G, Lalu M, Lavallee LT, Le T, Levine M, Love C, McCartney C, McMullen M, Bergamascki LM, Moore R, Mozel M, Nagpal S, Nantel J, Power B, Scheede-Bergdahl C, Tamblyn-Watts L, Thavorn K, Trottier D, van Walraven C, Yang I. Home-Based Prehabilitation for Older Surgical Patients With Frailty: A Randomized Clinical Trial. JAMA Surg. 2026 Feb 1;161(2):113-123. doi: 10.1001/jamasurg.2025.5288.

  PMID: 41335421 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.

  PMID: 25535730 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Baldini G, Ferreira V, Carli F. Preoperative Preparations for Enhanced Recovery After Surgery Programs: A Role for Prehabilitation. Surg Clin North Am. 2018 Dec;98(6):1149-1169. doi: 10.1016/j.suc.2018.07.004. Epub 2018 Aug 24.

  PMID: 30390849 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jordan Leitch, MSc, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah DuMerton

CONTACT

613-484-7322; deborah.dumerton@kingstonhsc.ca

Rachel Phelan

CONTACT

613-548-7827; rachel.phalen@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PGME Program Director and Assistant Professor - Department of Anesthesiology and Perioperative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 27, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

CA (1)