Patient Centred Models for Surveillance and Support of Cancer Survivors with Breast and Bowel Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 565
- 试验地点
- 1
- 主要终点
- Health related quality of life after cancer treatment
研究概览
简要总结
This project aims to enhance the support for patients with breast and bowel cancer after treatment. Current follow-up care includes either self-management with patient-initiated contacts (breast cancer) or scheduled hospital visits for scans/tests for recurrence (bowel cancer). Building on extensive experience with online patient self-reporting of symptoms during treatment, the study will develop, implement and evaluate satisfaction with an improved electronic system to engage breast and bowel cancer survivors to self-report symptoms/problems online from home and get immediate tailored advice for self-management or hospital contact. The reports are displayed real-time in the hospital records alongside scans/tests to inform clinical management.
详细描述
A structured plan of development, evaluation and implementation is proposed, based on the Medical Research Council (MRC) complex interventions framework and the principles of Action Research model (namely; Purpose choice on solving practical problems; Contextual focus; Data that helps track changes and sense making; Participation in research process and Knowledge diffusion). Action research is suited to identifying problems in clinical practice and helping develop potential solutions in order to improve practice. The study will use an experimental action research approach incorporating the action research cycle (Plan Do Study Act).
The effectiveness evaluation of patient/clinician acceptance, feasibility, patient benefits/satisfaction will be performed using a non-randomised 'Before-After study' approach, followed by immediate implementation in practice for faster patient benefits.
Main outcomes measured will include:
- Patient-Reported Outcomes questionnaires: quality of life, symptom control, and self-efficacy.
- Clinical measures: number of hospital contacts, recurrence rates.
- Process measures: survivors compliance with self-reports, clinical tests attendance; using online self-management resources.
The project will be structured in four phases:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast and colorectal healthcare professionals (e.g. Clinical Nurse Specialists) working at St James' University Hospital
- •Participating patients Phases 1 and 2:
- •Patients (aged 16 years or over) attending St James' University Hospital Bexley Wing, with breast and/or colorectal cancer in remission, completed their cancer treatment.
- •Able and willing to give informed consent
- •Able to read and understand English
- •Participating patients Phase 3:
- •Patients (aged 16 years or over) attending St James' University Hospital Bexley Wing, with breast and/or bowel (colorectal) cancer in remission, completed their cancer treatment.
- •Able and willing to give informed consent
- •Able to read and understand English
- •Access to the internet
排除标准
- •Patients under the age of 16
- •Patients exhibiting overt psychopathology/cognitive dysfunction
- •Patients taking part in other clinical trials involving the completion of extensive patient reported outcome or quality of life measures
结局指标
主要结局
Health related quality of life after cancer treatment
时间窗: 2021-2023
To assess the effects of the online intervention on participants' health related quality of life after cancer treatment for colorectal and breast. 1. Quality of Life in Adult Cancer Survivors scale (QLACS): Questions rated on a 1-7 point response scale, ranging from "never" to "always".
Disease Specific Quality of Life after cancer treatment in Breast- EORTC QLQ-BR49
时间窗: 2021-2023
1. European Organisation for Research and Treatment of Cancer: EORTC QLQ breast module respectively (BR49): Questions are rated on a 4-7 point scale and overall scale scores are calculated from 0-100 with higher scores indicating better quality of life.
Intervention engagement: participant withdrawals
时间窗: 2022-2023
To examine participants' engagement with the intervention. 1) Number of participant withdrawals from the study.
Clinician engagement
时间窗: 2022-2023
To examine clinicians' engagement with the intervention. Clinician qualitative end of study interviews.
Participant Recruitment
时间窗: 2021-2023
Recruitment, follow-up and attrition. 1. Number of potentially eligible patients, number approached, number recruited vs. number not recruited, reasons for ineligibility and reasons for non-consent. 2. Comparison of patient characteristics in before and after phase. 3. Number of withdrawals.
Intervention engagement: participants returning to routine follow-up.
时间窗: 2022-2023
To examine participants' engagement with the intervention. 1) Number of patients who moved back to routine follow-up (from remote follow-up).
Intervention engagement: Participants' views on the online system.
时间窗: 2022-2023
To examine participants' engagement with the intervention. 1) Participants qualitative interviews.
Disease Specific Quality of Life after cancer treatment in Colorectal - EORTC QLQ-CR29
时间窗: 2021-2023
1. European Organisation for Research and Treatment of Cancer: EORTC QLQ colorectal module respectively (CR29): Questions are rated on a 4-7 point scale and overall scale scores are calculated from 0-100 with higher scores indicating better quality of life.
次要结局
- Intervention implementation process measures: participant adherence(2022-2023)
- Patient Safety(2022-2023)
- National Health Service (NHS) Resources(2021-2023)
- Intervention implementation process measures: frequency of reported problems(2022-2023)
- Patients' Self-efficacy in managing their cancer(2021-2023)
研究者
Galina Velikova
Professor
University of Leeds