Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility Outcome Measure: Proportion of eligible patients recruited
研究概览
简要总结
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.
详细描述
See uploaded protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Adults who lack mental capacity.
- •Adults who do not understand spoken English.
- •Previous experience of prehabilitation.
- •Previous surgery for cancer
- •Pregnancy
结局指标
主要结局
Feasibility Outcome Measure: Proportion of eligible patients recruited
时间窗: From start of recruitment to recruitment closing. Approximately 6 months
E.g. number recruited compared with number eligible.
Feasibility Outcome Measure: Number of patients who decline and reasons for decline
时间窗: During recruitment period approximately 6 months
Number of patients who decline to take part in the study and reasons.
Feasibility Outcome Measure: Number of missed eligible patients
时间窗: From start of trial to recruitment closing. Approximately 6 months
Number of eligible patients not approached and reasons.
Feasibility Outcome Measure: Number of patients who remain in the trial for the full duration
时间窗: From recruitment through to three month post surgery follow up. (Approx 4 months total)
Retention of participants to trial and follow up. E.g. number of patients who remain in the trial until the follow up completed.
Feasibility Outcome Measure: Staff experiences of taking part in GoPREPARE trial
时间窗: At end of recruitment period. Approximately months 6-8
Staff experiences of delivering GoPREPARE trial. A focus group will be conducted at the end of the trial and experiences captured through thematic qualitative analysis.
Feasibility Outcome Measure: Participant experience of GoPREPARE
时间窗: 2 months after surgery, approximately 3 months after enrollment
Participant experience of GoPREPARE. Interviews will be undertaken and experience captured through qualitative thematic analysis.
次要结局
- Suitability and sensitivity of outcome measures: Return rate and completeness of questionnaires(From recruitment through to three month post surgery follow up. (Approx 4 months total))
- Suitability and sensitivity of outcome measures: Adverse events(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(In hospital stay approx 3-5 weeks following recruitment)
- Suitability and sensitivity of outcome measures: Physical Activity 1(At baseline for two weeks and at three months post surgery)
- Suitability and Sensitivity of Outcome Measures: Physical Activity 2(At baseline, prior to admission for surgery and at 3 months post surgery)
- Suitability and sensitivity of outcome measures: Average time participants wear their accelerometer(From recruitment for two weeks, for one further week at around 3 months post surgery.)
- Suitability and Sensitivity of Outcomes Measures: Smoking(At baseline, preadmission for surgery and three months follow-up post surgery.)
- Suitability and sensitivity of outcome measure: Alcohol Intake(At baseline, preadmission for surgery and at three month follow-up post surgery.)
- Suitability of sensitivity of outcome measurements: Incidence of postoperative morbidity/mortality(From discharge from hospital to three month follow up)
- Suitability and sensitivity of outcome measures: Post-operative recovery behaviour compliance(First three days after having had surgery)
- Suitability and Sensitivity of Outcome Measures: Health Related Quality of Life(At baseline, prior to admission for surgery and at three month follow up post surgery.)
- Suitability and Sensitivity of Outcome Measures: Nutrition 1(At baseline, before admission to hospital for surgery and at three month follow up post surgery)
- Suitability and Sensitivity of Outcome Measures: Nutrition 2(At baseline, prior to admission for surgery and at three month follow up post surgery)
- Suitability and Sensitivity of Outcome Measures: Mental Well-being(At baseline, before admission to hospital for surgery and at three month follow up post surgery)