A Study on Optimizing Follow-up for Postmenopausal Women With Breast Cancer Treated With Adjuvant Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- The difference in PREM (patient reported experience measure) as reported by patients in the individualized and standard follow-up groups, respectively
研究概览
简要总结
Background:
In February 2015 the Danish Health and Medicines Authority published new clinical guidelines describing how cancer patients should be followed. It is recommended that patients receiving specific oncological treatment such as endocrine therapy be followed at the department of oncology responsible for the treatment and providing the medication. There is no evidence that routine examinations improve overall survival after breast cancer. Mammography is the only specific examination to be offered to asymptomatic women after treatment for breast cancer
Aims of the study:
The hypothesis is that individualized follow-up with the introduction of Patient Reported Outcome (PRO) data will help postmenopausal women regain control of health related self-care and encourage them to a larger extent to take part in their follow-up after cancer treatment. This is believed to improve the health related quality of life and increase the positive experience of the follow-up program.
Design:
Patients are randomly assigned to the department's standard control program or an individualized solution in the context of shared decision making. PRO data will be used to evaluate the patient's need for consultations.
Primary outcome:
Evaluation of the experience and feasibility of PRO data in connection with individualized follow-up of postmenopausal women with breast cancer. Systematically applying PRO data we will uncover patient needs, empower the patients to take part in shared decision making, and improve the current follow-up in the sense of a more patient-centered care and tailored follow-up.
详细描述
Introduction
The purpose of the present follow-up program, after treatment for early stage breast cancer, is to detect local and systemic recurrences, new primary tumors in the breasts, and secondary cancer. Furthermore, the clinicians aim to provide the patients with social and psychological support, if needed, and support them in managing side effects to their primary treatment and current endocrine therapy.
Patient reported outcomes (PRO)
It has been demonstrated that clinicians systematically underestimate patient symptoms, and that many symptoms go unrecognized. Patients frequently deal with symptoms of both physical and psychological origin between visits and may have been carrying them for an unacceptable period of time, because of the natural thresholds for calling the department. Also, they may forget to communicate the symptoms at their appointment in the clinic. If the symptoms persist and are revealed at the consultation, they are commonly more severe to the patient at this time than when they first appeared.
Information about the patient's individual symptoms and health status during cancer treatment and follow-up is currently obtained by the clinician as part of the communication with the patient. This approach is not systematic and cannot be used to monitor symptoms development over time. However, knowledge of health status is essential for assessing and improving well-being and rehabilitation in cancer care aiming the best possible outcome. Fewer symptoms may thus be an indication of whether supportive care has been effective, while the appearance of new symptoms may reflect recurrence in an early stage. Electronic registration of systemically obtained PRO data in clinical practice can be a method to improve the quality of the follow-up program .
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
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal at the time of diagnosis (menostasis > 12 months. Bilateral salpingo-oophorectomy)
- •Complete disease remission after primary operation
- •Histologically confirmed hormone-receptor positive breast cancer, 1% or more of the tumor cells express hormone receptors
- •High-risk profile with a 10-year recurrence of more than 10%
- •Planned adjuvant endocrine therapy regardless of other adjuvant therapy to be initiated within 1 month or initiated within the last 9 months.
- •Written and verbally informed consent
- •Able to read and speak Danish
- •Access to a computer and an email-account
排除标准
- •Patient followed regularly as part of a research protocol
- •Women postmenopausal due to surgery on the ovaries/uterus age < 50
- •Prognostic low grade risk of recurrence (tumor size 10 mm or less, lymph node negative, ductal carcinoma grade 1 and lobular carcinoma grade 1 or 2)
结局指标
主要结局
The difference in PREM (patient reported experience measure) as reported by patients in the individualized and standard follow-up groups, respectively
时间窗: 2 years
Every three months the patients in both groups are requested to fill out a patient satisfaction questionnaire (PEQ) concerning their follow-up program. A single item with scores between 1 and 5 will be used to evaluate the difference between the 2 groups (1 is very satisfied and 5 is very dissatisfied)
次要结局
- Comparison of Health related quality of life in the individualized follow-up versus standard follow-up.(2 years)
- Evaluation of current information level during primary treatment(2 years)
- The difference in CollaboRATE-score between the individualized and standard follow-up.(2 years)
- Elucidation of issues of importance and concern to postmenopausal woman with breast cancer in adjuvant endocrine therapy during follow-up after primary treatment. What symptoms and side effects trouble them most during follow-up?(2 years)
- Comparison of resources spent on individualized follow-up based on PRO-data and standard follow-up.(2 years)