Short summary

This study aims to optimize follow-up care for postmenopausal women who have successfully been treated for early stage breast cancer, but due to the risk of recurrence, is recommended 5 years adjuvant endocrine therapy. Studies have shown a discrepancy between patients' expectations and needs during follow-up and the expectations from the clinicians who are responsible for taking care of these women. So in order to create a more shared agenda and purpose of follow up care, we will use patient reported outcomes (PROs) to customize clinical visits to the patients' needs.

Rationale

Breast cancer is the most frequent type of cancer among women, with the highest incidence at the age of 60 or more. It is estimated that there will be about 4.200 new incidences of breast cancer a year in the Danish population in the coming years. Approximately 96% of the patients are living 1-year after diagnosed with the disease and 85% after 5-years.

Hormone receptor-positive tumors accounts for approximately 75% of all breast cancers. The adjuvant treatment is decided by presence of different prognostic characteristics and risk factors. Medical treatment after surgery is recommended when the risk of recurrence is ? 10% within a 10 years period. Expression of hormone receptors at the surface of the tumor cells, predicts benefit of adjuvant endocrine therapy. For postmenopausal women with hormone-receptor positive disease the recommendations from the Danish Breast Cancer Group (DBCG) are 5 years of adjuvant endocrine treatment with an aromatase inhibitor.

In February 2015 the Danish Health and Medicines Authority published new clinical guidelines describing how cancer patients should be followed. It is pointed out that patients who receive specific oncological treatment, like endocrine therapy, is recommended to be followed at the oncological department who is responsible for the treatment and provides the patients with the medication. There is no evidence that routine examinations improves overall survival after breast cancer. Mammography is the only specific examination to be offered to asymptomatic women, after treatment for breast cancer. Patient-reported outcome (PRO)

It has been demonstrated that clinicians systematically underestimate patients' symptoms, and that many symptoms go unrecognized. Patients frequently deal with symptoms of both physically and mentally origin between visits and either forgot to communicate those symptoms when they reach their appointment at the office or have been carrying around these complaints for an unacceptable period, because of the natural thresholds for calling the department. If the symptoms persist and are revealed at the consultation, they are commonly more severe to the patient, then at the time of appearance. 

Information about the patients' 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 neither systemic, nor can it be used to monitor symptom development over time. Knowledge of health status is however 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 Patient Reported Outcome in clinical practice can be a method to improve the quality of the follow up program. 

PRO-data is information about patients' experienced symptoms, functional capacity and quality of life and has not yet been implemented as a systemically obtained measurement in the follow up program. According to the US Food and Drug Administration (FDA) PRO-data is: "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else". PRO-data is typically collected through a questionnaire in which measurements are repeated over time. This allows continuous monitoring of patients' health status. PRO-data is a tool to improve healthcare quality and is the key to alter how healthcare is organized and delivered in a beneficial way for the patients. Implementation of PRO-data faces several challenges, due to the extra efforts from the staff, the development of appropriate electronic equipment for the task and to determine the prober use and aspects in different parts of the health care system.

The population of patients who survive breast cancer is growing. This calls for more and better supportive care and rehabilitation during follow-up. Providing information that is congruent with patients' needs is important to denote patient involvement, patient satisfaction and might also affect health-related quality of life of cancer survivors.

The new clinical guidelines from the Danish Health and Medicines Authority aims at providing the patients with an individual follow up after primary cancer treatment and claim that the current resources can be used more efficiently. Exactly how this is to be done is still unclear, due to the lack of evidence on the area.

Description of the cohort

Postmenopausal women > 50 years old. Diagnosed with hormone receptor possitive early stage breast cancer. Completed radical operation and initiated, or offered, adjuvant endocrine therapy within the last 9 month from inclusion  

Data and biological material

Data from questionnaires

Data from medical records

Collaborating researchers and departments

Department of oncology, Vejle hospital

• PhD-student Cathrine Lundgaard Riis MD  
• Consultant MD Troels Bechmann

Center for shared decision making, Hospital Lillebælt, Nuffield Department of Population Health, University of Oxford, Professor Angela Coulter

Department of Gynecology and Obstetrics, Odense University Hospital, Professor Pernille Tine Jensen

Publications associated with the project

A scoping review on the proactive use of PROs in follow-up care for early stage breast cancer is nearly done