CONTACT: A Prospective Interventional Multicentre Before-after Study for the Implementation of a Care Pathway to Increase Self-management of Patients With Cancer Who Are Treated With Oral Anticancer Medications
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 228
- 试验地点
- 8
- 主要终点
- Change in self-management skills
研究概览
简要总结
This study aims to develop, implement and evaluate a care pathway for patients with cancer who are treated with oral anticancer drugs (OACD).
The care pathway will be developed in six hospitals in Flanders, and will be adapted to the local setting and situation.
The investigators hypothesize that the implementation of a care pathway will increase the quality of the drug therapy, the communication between health care professionals (HCPs) and patients, and will lead to an improved level of self-management and adherence. Moreover, the invesitgators hypothesize that the care pathway will facilitate the communication between HCPs in the hospital setting and in ambulatory care, and will improve counseling skills, self-efficacy and self-confidence of HCPs.
At the end of the study, a roadmap for the nation-wide implementation of a similar care pathway will be constructed based on the experiences of the participating hospitals. This roadmap will certainly include an e-learning platform for healthcare professionals.
详细描述
For each hospital, an individual care pathway will be developed following the 7-phase model by Vanhaecht et al., 2011. This methodology aims to offer a systematic approach in 7 phases for the support of an interdisciplinary team in the development of new care pathways or in the improvement of existing ones.
The before-part of the study includes phases 1 to 4 that aim to map current practice in detail and to translate these findings into the development of a care pathway. Current practice will be investigated using mixed methods comprising:
- surveys evaluating care on the level of the hospital
- semi-structured interviews with healthcare professionals (HCP) and patients
- outcome assessments in patients included in the study (self-management, adherence, satisfaction with care, satisfaction with information, quality of life) using validated questionnaires at the start of the therapy, after 1 month and after three months
- outcome assessments in healthcare professionals at baseline (self-efficacy and perceptions on self-management) using validated questionnaires
- training and feedback sessions on counseling for HCPs
Based upon these findings, a care pathway in each hospital will be developed by a local project team of different stakeholders from different disciplines.
The after-part of the study includes phase 5-7 in which the care pathway is implemented, evaluated and continuously followed up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •a hematological cancer of solid tumor
- •starting an oral anticancer drug for the first time
- •able to understand and speak Dutch
排除标准
- •patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
- •patients following a therapy with a study drug
研究组 & 干预措施
Non-care pathway
This arm comprises patients before the implementation of the care pathway. Patients starting with an oral anticancer therapy participate in the current care process. Outcomes are assessed at start of treatment, after 1 and after 3 months.
The decision to start with an oral anticancer therapy depends solely on the treating physician.
Care Pathway
This arm comprises patients after the implementation of the care pathway. Patients starting with an oral anticancer therapy in this arm, receive care as is described by the novel designed care pathway. Outcomes are again assessed at start of treatment, after 1 and after 3 months.
The decision to start with an oral anticancer therapy depends solely on the treating physician.
干预措施: Implementation of a care pathway (Other)
结局指标
主要结局
Change in self-management skills
时间窗: at the start of the therapy, after one and three months
There is no gold standard to define self-management. A definition from Barlow et al., 2002 (2) defines self-management as follows: the ability of an individual to manage the symptoms, treatment, physical and psychosocial consequences and life style changes due to his/her condition. Adequate self-management refers to the ability to monitor one's condition and to effect cognitive, behavioural and emotional responses necessary to maintain a satisfactory quality of life. The studied self-management skills in this project comprise "social integration and support", "health service navigation", "constructive attitudes and approaches", "skill and technique acquisition" and "emotional distress".
次要结局
- Change in medication Adherence(after one and three months of therapy)
- Health Related Quality of Life(at the start of the therapy, after one and three months)
- Toxicity of treatment(at the start of the therapy, after one and three months)
- Change in patient satisfaction with care using Out-patsat 35(at the start of the therapy, after one and three months)
- Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)(after one and three months)
- Change in Distress using the Distress Barometer(at the start of the therapy, after one and three months)
- Efficacy of treatment Using ECOG performance scale and RECIST criteria(at the start of the therapy, after one and three months)
- Cost of care(at the start of the therapy, after one and three months)