A Study on Optimizing Follow-up for Postmenopausal Women With Breast Cancer Treated With Adjuvant Endocrine Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 .

      PRO data is information about patient 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 are
      typically collected through a questionnaire in which measurements are repeated over time.
      This allows continuous monitoring of the patient health status. PRO data is a tool to improve
      healthcare quality and the key to organize and deliver healthcare in a way beneficial to the
      patients. Today, PRO data are not routinely obtained during follow-up, but the new guidelines
      from the Danish Health and Medicines Authority recommend the use of PRO data. The
      implementation faces several challenges due to the extra effort by the staff, the development
      of appropriate electronic equipment, and determination of the proper use in different parts
      of the healthcare system.

      Providing information congruent with patient needs is important to denote patient involvement
      and satisfaction, and it may also affect the health-related quality of life. Shared decision
      making is one of the most recent models fostered by healthcare research and aims to establish
      a partnership between the healthcare professional and the patient. The model describes how
      decisions should be made. It is centered on the idea that the healthcare professional
      communicates medical knowledge to the patient, and that the patient's perspectives,
      preferences and rights are included in the clinical conversation. The exchange of knowledge
      and information is one of the most important preconditions to carry out shared decision
      making in clinical practice.

      The study is a randomized trial in which patients are assigned to the department's standard
      follow-up program or to individualized follow-up in the context of shared decision making
      with PRO-data guiding the clinician as to the patient's need for consultations in the clinic
      by a nurse, doctor, physiotherapist, social workers and/or psychologist. The individual
      follow-up program also offers the possibility of consulting a sexologist and a coach,
      probably with an extent of self-payment. In both programs the patients can call the
      department and make arrangement for an urgent appointment. Only the individualized program
      offers email consultation and patient influence as to how much effort they want to spend on
      their follow-up.

      Data collection:

      PRO data will be handled electronically in the software program SurveyXact, where the
      patients obtain access to different questionnaires through secured links.

      The clinicians and nurses who take care of the patients in either of the programs are
      requested to fill out a brief questionnaire after seeing each patient to register the
      complaints or concerns that led to the contact, and what was to solve the problem. In
      compliance with departmental guidelines, the patients will be recommended supportive medical
      care, referred to physiotherapy, plastic surgery, or extraordinary imaging.

      The patients in both programs are also requested to fill out a patient satisfaction
      questionnaire after each consultation and a CollaboRATE questionnaire containing three brief
      questions to measure the level of shared decision making.

      Perspectives:

      The socioeconomic aspects related to the introduction of a patient centered, individualized
      follow-up program, where resources are spent on those in need of them, are of great
      importance in the Danish healthcare system. The results of this study can be used nationally
      in providing tailored follow-up to this group of patients.
    

Intervention name(s): Individualized, tailored follow-up program
Intervention type(s): Behavioral
Intervention description(s): Individualized follow-up in the context of shared decision making, with the use of PRO-data to evaluate the patient needs of consultations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: PRO, follow up