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Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Ovarian Cancer Surgery (ADAPT-OC)

2026. május 19. frissítette: Jordan Leitch

Assessing Delivery Approaches for Prehabilitation Trials in Ovarian 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 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

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

36

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

    • Ontario
      • Kingston, Ontario, Kanada, K7L 2V7

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Támogató gondoskodás
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: In-Person Prehabilitation
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.
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.
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.
Kísérleti: Remote Prehabilitation
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.
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.
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.
Aktív összehasonlító: Education Only
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.
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Behavioural adherence to exercise target (≥10 MET-hours/week)
Időkeret: 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%)
Enrolment to preoperative assessment (3-6 weeks)
Patient preference for delivery model
Időkeret: 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.
Quantitative: Enrolment to preoperative assessment (3-6 weeks). Qualitative: baseline and 4-week postoperative interviews.

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Recruitment rate
Időkeret: 12-month recruitment period
Proportion of eligible patients approached who consent and enroll.
12-month recruitment period
Retention rate
Időkeret: Enrolment to 4-week postoperative assessment
Proportion of enrolled participants completing all study assessments through 4-week postoperative follow-up.
Enrolment to 4-week postoperative assessment
Intervention adherence
Időkeret: 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.
Enrolment to preoperative assessment
Adverse events
Időkeret: Enrolment to 4-week postoperative assessment
Any medical events potentially related to exercise, nutrition, or behavioural intervention components.
Enrolment to 4-week postoperative assessment
Semi-structured interviews
Időkeret: Enrolment and 1-3 days preoperative
Qualitative assessment of acceptability, barriers, facilitators, coaching experience, and web application usability; analysed via thematic analysis.
Enrolment and 1-3 days preoperative
Cardiorespiratory Fitness (VO2max)
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
Handgrip strength (kg)
Időkeret: Baseline, preoperative, 4 weeks postoperative

Handheld dynamometer: average of 3 trials in dominant hand.

Higher number indicates greater forearm strength.

Baseline, preoperative, 4 weeks postoperative
30sec Sit to Stand
Időkeret: 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.

Baseline, preoperative, 4 weeks postoperative
30sec Arm Curl
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
BMI (kg/m^2)
Időkeret: Baseline, preoperative, 4 weeks postoperative
Height (m) and weight (kg) used to compute BMI (kg/m^2)
Baseline, preoperative, 4 weeks postoperative
Body Fat Percentage
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
Quality of Life (FACT-G)
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
Nutritional Status (PG-SGA SF)
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
Anxiety & Depression (HADS)
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative
Functional Impairment / Disability (WHODAS 2.0)
Időkeret: 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.
Baseline, preoperative, 4 weeks postoperative

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Nyomozók

  • Kutatásvezető: Jordan Leitch, MSc, MD, FRCPC, Queen's University

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. május 14.

Elsődleges befejezés (Becsült)

2027. május 14.

A tanulmány befejezése (Becsült)

2027. május 14.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. május 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 19.

Első közzététel (Tényleges)

2026. május 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 27.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. május 19.

Utolsó ellenőrzés

2026. május 1.

Több információ

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