PrehabilitationADAPTNCT07609082
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
A study testing Multimodal Prehabilitation Program and Educational Materials in people with Prehabilitation and Preoperative Aerobic Training, run by Jordan Leitch at 1 site in Canada.
Trial 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 primary surgery for suspected gynecologic malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prehabilitation, Preoperative Aerobic Training, Preoperative Care
- What is being tested?
- Multimodal Prehabilitation Program and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2027to 14 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged ≥18 years
- Scheduled for cytoreductive surgery for a gynecologic 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
Who cannot join
- Pregnancy
- Cervical pathologies
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Deborah DuMerton, 613-484-7322, deborah.dumerton@kingstonhsc.ca
Rachel Phelan, 613-548-7827, rachel.phalen@kingstonhsc.ca
About this study
Official title: Assessing Delivery Approaches for Prehabilitation Trials in Gynecologic Cancer: A Pilot Feasibility Patient-Preference 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 primary surgery for suspected gynecologic malignancy. It will also examine which delivery model patients prefer and the factors influencing patient preferences.
The main questions ADAPT aims to answer are:
Read more
- Can participants achieve the prescribed aerobic exercise target of at least 10 MET-hours per week before surgery?
- 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 gynecologic cancer.
Participants will:
- Choose their preferred study group, or be randomly assigned if they have no preference
- Complete patient-reported questionnaires and semi-structured 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
Read the detailed description
Assessing Delivery Approaches for Prehabilitation Trials in Gynecologic Cancer (ADAPT) 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 a gynecologic mass suspicious of malignancy. Findings from this pilot study will inform future work.
Postoperative complications remain common after gynecologic oncology surgery. 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 patients with suspected gynecologic cancer is unknown.
Participants will be women aged 18 years or older undergoing surgery for a gynecologic 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 three 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 patient-reported quality of life, nutritional status, anxiety and depression, disability, postoperative complications, hospital length of stay, and time to neoadjuvant 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.
- Conditions
- Prehabilitation, Preoperative Aerobic Training, Preoperative Care, Exercise Therapy, Postoperative Outcomes, Gynecologic Cancers
- Being tested
- Multimodal Prehabilitation Program, Educational Materials
- Keywords
- postoperative outcomes, prehabilitation, nutritional support, psychological support, exercise therapy, gynecologic cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Prehabilitation ProgramBehavioural
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 MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 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.
Measured: Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.
Secondary outcomes (9)
Recruitment rate
Proportion of eligible patients approached who consent and enroll.
Measured: 12-month recruitment period
Retention rate
Proportion of enrolled participants completing all study assessments through 4-week postoperative follow-up.
Measured: Enrolment to 4-week postoperative assessment
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.
Measured: Enrolment to preoperative assessment
Adverse events
Any medical events potentially related to exercise, nutrition, or behavioural intervention components.
Measured: Enrolment to 4-week postoperative assessment
Semi-structured interviews
Qualitative assessment of acceptability, barriers, facilitators, coaching experience, and web application usability; analysed via thematic analysis.
Measured: Enrolment and 1-3 days preoperative
Quality of Life (FACT-G)
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.
Measured: Baseline, preoperative, 4 weeks postoperative
Nutritional Status (PG-SGA SF)
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.
Measured: Baseline, preoperative, 4 weeks postoperative
Anxiety & Depression (HADS)
Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression. Total range: 0-42, higher scores indicate worse psychological distress.
Measured: Baseline, preoperative, 4 weeks postoperative
Functional Impairment / Disability (WHODAS 2.0)
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.
Measured: Baseline, preoperative, 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start14 May 2027 (estimated)
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Leitch
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Queen's University
- Responsible party
- Sponsor-investigator, Jordan Leitch, Queen's University
- Investigators
- Jordan Leitch, MSc, MD, FRCPC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609082
- Sponsor's protocol ID
- ADAPT Pilot
- Acronym
- ADAPT
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the study, specifically data underlying the primary and exploratory outcomes and adherence metrics, may be shared with qualified researchers for secondary analyses, including systematic reviews and meta-analyses, upon reasonable request. Data sharing will be limited to information covered by participant consent and applicable privacy and confidentiality requirements.
Publications
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.
PubMed 39843215McIsaac 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.
PubMed 41335421Michie 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.
PubMed 21513547Watts 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.
PubMed 38709465Rose 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.
PubMed 35579479Iyer 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.
PubMed 25535730Fleurent-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.
PubMed 38677949McIsaac 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.
PubMed 34922735Baldini 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.
PubMed 30390849
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Delivery Approaches for Prehabilitation Trials in Gynecologic Cancer: A Pilot Feasibility Patient-Preference Trial
- ClinicalTrials.gov ID
- NCT07609082
- Acronym / sponsor ID
- ADAPT / ADAPT Pilot
- Conditions
- Prehabilitation, Preoperative Aerobic Training, Preoperative Care, Exercise Therapy, Postoperative Outcomes, Gynecologic Cancers
- Keywords
- postoperative outcomes, prehabilitation, nutritional support, psychological support, exercise therapy, gynecologic cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jordan LeitchUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Queen's University
- Study start
- 14 May 2027 (estimated)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 primary surgery for suspected gynecologic malignancy. It will also examine which delivery model patients prefer and the factors influencing patient preferences.
The main questions ADAPT aims to answer are:
- Can participants achieve the prescribed aerobic exercise target of at least 10 MET-hours per week before surgery?
- 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 gynecologic cancer.
Participants will:
- Choose their preferred study group, or be randomly assigned if they have no preference
- Complete patient-reported questionnaires and semi-structured 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 Gynecologic Cancer (ADAPT) 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 a gynecologic mass suspicious of malignancy. Findings from this pilot study will inform future work.
Postoperative complications remain common after gynecologic oncology surgery. 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 patients with suspected gynecologic cancer is unknown.
Participants will be women aged 18 years or older undergoing surgery for a gynecologic 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 three 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 patient-reported quality of life, nutritional status, anxiety and depression, disability, postoperative complications, hospital length of stay, and time to neoadjuvant 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-Person Prehabilitation | Experimental | Behavioral: Multimodal Prehabilitation Program, Other: Educational MaterialsParticipants 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 MaterialsParticipants 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 MaterialsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Aged ≥18 years
- Scheduled for cytoreductive surgery for a gynecologic mass suspected or confirmed of cancer
- Surgery planned ≥3 weeks from time of booking
- No contraindications to exercise on the CSEP Get Active Questionnaire
Key exclusion criteria (7 listed)
- Pregnancy
- Cervical pathologies
- Surgery scheduled <3 weeks from booking
- Receiving neoadjuvant chemotherapy
- Positive contraindications to exercise on the CSEP Get Active Questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Prehabilitation ProgramThe 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. | Behavioural | In-Person Prehabilitation, Remote Prehabilitation |
| Educational MaterialsParticipants 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. | Other | Education Only, In-Person Prehabilitation, Remote Prehabilitation |
Primary outcome
Behavioural adherence to exercise target (≥10 MET-hours/week)
Time frame: 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
Time frame: 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.
9 secondary outcomes
Recruitment rate
Time frame: 12-month recruitment period
Retention rate
Time frame: Enrolment to 4-week postoperative assessment
Intervention adherence
Time frame: Enrolment to preoperative assessment
Adverse events
Time frame: Enrolment to 4-week postoperative assessment
Semi-structured interviews
Time frame: Enrolment and 1-3 days preoperative
Quality of Life (FACT-G)
Time frame: Baseline, preoperative, 4 weeks postoperative
Nutritional Status (PG-SGA SF)
Time frame: Baseline, preoperative, 4 weeks postoperative
Anxiety & Depression (HADS)
Time frame: Baseline, preoperative, 4 weeks postoperative
Functional Impairment / Disability (WHODAS 2.0)
Time frame: Baseline, preoperative, 4 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 39843215McIsaac 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.
- Background: PubMed 41335421McIsaac 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.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the study, specifically data underlying the primary and exploratory outcomes and adherence metrics, may be shared with qualified researchers for secondary analyses, including systematic reviews and meta-analyses, upon reasonable request. Data sharing will be limited to information covered by participant consent and applicable privacy and confidentiality requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordan Leitch, MSc, MD, FRCPC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation Program and Educational Materials in people with Prehabilitation and Preoperative Aerobic Training, run by Jordan Leitch at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah DuMerton (613-484-7322, deborah.dumerton@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural adherence to exercise target (≥10 MET-hours/week) (time frame: Enrolment to preoperative assessment (3-6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07609082, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.