Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Ovarian Cancer Surgery (ADAPT-OC)
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:
- 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 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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Deborah DuMerton
- 電話番号:613-484-7322
- メール:deborah.dumerton@kingstonhsc.ca
研究連絡先のバックアップ
- 名前:Rachel Phelan
- 電話番号:613-548-7827
- メール:rachel.phalen@kingstonhsc.ca
研究場所
-
-
Ontario
-
Kingston、Ontario、カナダ、K7L 2V7
- Kingston Health Sciences Centre
-
コンタクト:
- Deborah DuMerton
- 電話番号:613-484-7322
- メール:deborah.dumerton@kingstonhsc.ca
-
コンタクト:
- Rachel Phelan
- 電話番号:613-548-7827
- メール:rachel.phalen@kingstonhsc.ca
-
主任研究者:
- Jordan Leitch, MSc, MD, FRCPC
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
|
実験的: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.
|
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Behavioural adherence to exercise target (≥10 MET-hours/week)
時間枠: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
時間枠: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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠:12-month recruitment period
|
Proportion of eligible patients approached who consent and enroll.
|
12-month recruitment period
|
|
Retention rate
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jordan Leitch, MSc, MD, FRCPC、Queen's University
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ADAPT-OC Pilot
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
卵巣がんの臨床試験
-
Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer(NSCLC) | KRAS G12変異NSCLC | 食道扁平上皮がん(SCC) | ヘッド/ネックSCC | 進行した胃腸間質腫瘍(GIST) | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Multimodal Prehabilitation Programの臨床試験
-
Texas Scottish Rite Hospital for Childrenまだ募集していません
-
Saglik Bilimleri UniversitesiAnkara Oncology Research and Training Hospital積極的、募集していない
-
Children's Health完了
-
AdventHealthState of Florida Department of Health募集
-
Brown UniversityHarvard University; West Virginia University; Canandaigua VA Medical Center; The Warren Alpert Foundation積極的、募集していない