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

19 maggio 2026 aggiornato da: 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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Behavioural adherence to exercise target (≥10 MET-hours/week)
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment rate
Lasso di tempo: 12-month recruitment period
Proportion of eligible patients approached who consent and enroll.
12-month recruitment period
Retention rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

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

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

14 maggio 2026

Completamento primario (Stimato)

14 maggio 2027

Completamento dello studio (Stimato)

14 maggio 2027

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

27 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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