A Randomised Study Comparing Satisfaction With Individualised Follow-up Led by a Trained Cancer Nurse Versus Conventional Medical Follow-up After Primary Treatment for Ovarian Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 3
- 主要终点
- The European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire QLQ-C30 with ovarian cancer specific module Ov-28.
研究概览
简要总结
The purpose of this study in women who have completed primary treatment for ovarian cancer is to investigate the effects of individualised follow-up care delivered by a nurse compared to conventional medical follow-up on quality of life and mood. The investigators aim to determine if the individualised treatment is acceptable to women compared to the conventional treatment.
详细描述
There is recent evidence that routine cancer follow-up is ineffective (Kew, 2011). Knowledge of how best to deliver follow-up remains inadequate and randomised studies are lacking. This trial compares individualised follow-up led by a cancer trained nurse to conventional medical follow-up.
Aim:
The investigators shall conduct the trial using experienced clinical nurse specialists (CNSs) to deliver self-management focused individual follow-up and evaluate whether this brings about greater improvement in quality of life, is acceptable and cost saving when compared to the standard (conventional) model.
Design:
Two arm randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ovarian cancer (includes fallopian tube and peritoneal cancers)
- •Within one month of completion of primary treatment including surgery & chemotherapy/radiotherapy or surgery alone, irrespective of outcome with regard to remission
- •Expected survival ≥3 months
- •Agreement to be randomised
- •Agreement to give written consent to participate in the study
- •Sufficient grasp of English to engage in the self-management focused approach.
排除标准
- •A second cancer diagnosis
- •Clinician estimated survival of ≤ 3 months
- •Women receiving treatment for a mental health condition
- •Women who have a learning disability.
研究组 & 干预措施
Conventional follow-up
Treatment as usual will involve: one post treatment appointment then 3 monthly appointments with a Dr. At appointments: medical history; investigations to monitor disease progression including CA125 tumour marker blood test if this were raised at diagnosis. A physical examination may be performed.
Individualised follow-up
Follow-up is delivered by a nurse and frequency and type (telephone or face-to-face) is negotiated to suit their individual situation. Assessment by holistic guide. The intervention is informed by a model of health promoting interactions oriented towards improving self-efficacy. The nurses will provide information and support to help patients manage symptoms and psychological discomfort.
干预措施: Individualised follow-up (Behavioral)
结局指标
主要结局
The European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire QLQ-C30 with ovarian cancer specific module Ov-28.
时间窗: Assessment of change over time from baseline and at 3, 6, 12,18, & 24 months.
is a 30-item questionnaire assessing five 5 functional domains (physical, role, cognitive, emotional and social), 3 symptom domains (nausea/vomiting, fatigue and pain), and a number of specific symptoms (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea) as well as the perceived financial impact of the disease and treatment.The site specific instrument (Ov-28) used with the QLQ-C30 consists of 28 items which are factor analysed into six factors: abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side effects specific to ovarian cancer treatments, hormonal symptoms, body image and sexuality, and attitude to disease/treatment. Higher scores for functioning subscales indicate better functioning. Higher scores in symptom subscales indicate worse symptoms.
次要结局
- Hospital Anxiety and Depression Scale (HADS):(Assessment of change over time from baseline and at 3, 6, 12, 18, & 24 months.)