Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial

Официальное название

Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)

Обзор

One in four patients requiring planned major surgery have complications. Prehabilitation; which involves increasing physical activity, improving nutrition and supporting emotional well-being prior to surgery can reduce these complications and improve recovery. Group preoperative prehabilitation classes (surgery schools) are advocated by the Centre for Perioperative Care and are standard care in many hospitals, despite a lack of evidence for their effectiveness in improving patient outcomes. In phase 1 an 2 of this research investigators used patient experiences and co-participatory methods to optimise an existing intervention to make it as acceptable and as engaging as possible. The resulting education package is called 'GoPREPARE' Investigators now intend to test the practicalities of trialing GoPREPARE on preoperative patients with cancer. 24 patients awaiting surgery will be recruited from University Hospital Plymouth and randomly allocated equally to: Group - GoPREPARE and Group 2- standard care. Participants will complete lifestyle questionnaires before during and after their hospital stay. To evaluate the experience, \~8 participants will be interviewed. 5 clinical staff involved in the trial will also take part in a focus group. The information collected will be analysed to assess if it is feasible to conduct a larger trial.

Подробное описание

See uploaded protocol

Вмешательства

• Другое GoPREPARE
  GoPREPARE is a live interactive virtual education and behaviour change intervention delivered by healthcare professionals to groups of patients and their family, friends and carers which aims to prepare them for major cancer surgery.

Первичные конечные точки

• Feasibility Outcome Measure: Proportion of eligible patients recruited [Срок оценки: From start of recruitment to recruitment closing. Approximately 6 months]
• Feasibility Outcome Measure: Number of patients who decline and reasons for decline [Срок оценки: During recruitment period approximately 6 months]
• Feasibility Outcome Measure: Number of missed eligible patients [Срок оценки: From start of trial to recruitment closing. Approximately 6 months]
• Feasibility Outcome Measure: Number of patients who remain in the trial for the full duration [Срок оценки: From recruitment through to three month post surgery follow up. (Approx 4 months total)]
• Feasibility Outcome Measure: Participant experience of GoPREPARE [Срок оценки: 2 months after surgery, approximately 3 months after enrollment]
• Feasibility Outcome Measure: Staff experiences of taking part in GoPREPARE trial [Срок оценки: At end of recruitment period. Approximately months 6-8]

Вторичные конечные точки (12)

• Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires [Срок оценки: From recruitment through to three month post surgery follow up. (Approx 4 months total)]
• Suitability and sensitivity of outcome measures: Average time participants wear their accelerometer [Срок оценки: From recruitment for two weeks, for one further week at around 3 months post surgery.]
• Suitability and sensitivity of outcome measures: Adverse events [Срок оценки: From recruitment through to three month post surgery follow up. (Approx 4 months total)]
• Suitability and sensitivity of outcome measures: Number of days spent in hospital following surgery [Срок оценки: In hospital stay approx 3-5 weeks following recruitment]
• Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality [Срок оценки: From discharge from hospital to three month follow up]
• Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance [Срок оценки: First three days after having had surgery]
• Suitability and sensitivity of outcome measures: Physical Activity 1 [Срок оценки: At baseline for two weeks and at three months post surgery]
• Suitability and Sensitivity of Outcome Measures: Physical Activity 2 [Срок оценки: At baseline, prior to admission for surgery and at 3 months post surgery]
• Suitability and Sensitivity of Outcome Measures: Health Related Quality of Life [Срок оценки: At baseline, prior to admission for surgery and at three month follow up post surgery.]
• Suitability and Sensitivity of Outcome Measures: Nutrition 1 [Срок оценки: At baseline, before admission to hospital for surgery and at three month follow up post surgery]
• Suitability and Sensitivity of Outcome Measures: Nutrition 2 [Срок оценки: At baseline, prior to admission for surgery and at three month follow up post surgery]
• Suitability and Sensitivity of Outcome Measures: Mental Well-being [Срок оценки: At baseline, before admission to hospital for surgery and at three month follow up post surgery]

Критерии участия

Критерии включения

• Adults undergoing elective surgery for any body cavity cancer with curative intent.
• Adults with more than 3 weeks before planned surgery
• Adults without previous experience of prehabilitation.

Критерии исключения

• Children
• Adults who lack mental capacity.
• Adults who do not understand spoken English.
• Previous experience of prehabilitation.
• Previous surgery for cancer
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Великобритания · 1 центр

• University Hospitals Plymouth NHS Trust — Plymouth

Идентификаторы

NCT: NCT07278622 · RHM CRI0467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗