OPEN Research Support

PhD student
Trine A. Gregersen
Department of Health Research, Lillebaelt Hospital, Vejle

Projekt styring
Projekt status    Sampling ongoing
Data indsamlingsdatoer
Start 01.05.2015  
Slut 31.12.2019  

Clinical trial or standard treatment. Shared decision-making at the department of oncology

Short summary

The project is based on a patient-oriented problem that deals with cancer patients and the difficult treatment choices they often have to make. Cancer patients have many treatment options to consider, including participation in clinical trials where patients are testing new drugs or methods. The life-threatening nature of the disease complicates the decision-making process and places high demands on the healthcare professionals' ability to involve the patient in the decisions. The purpose of the project is to investigate the decision-making process when cancer patients can be included in a clinical trial.



Progress within cancer treatment builds on clinical trials testing new drugs and methods, and in 2013, 2,025 patients participated in different clinical trials within oncology in Denmark (4). When breast cancer patients have been diagnosed, they need to choose between a wide range of treatment options, including participation in clinical trials, and the life threatening nature of the disease complicates the decision making process. It can be overwhelming to be a cancer patient and at the same time be required to decide whether or not to participate in a clinical trial. In many cases the difference between pros and cons of treatment options and clinical trials is small or unsure, and today there is general agreement that the choice should be based on the patient's preferences . This requires a strong ability of the health care providers to give advice and involve the patient in the decision making process.  

Therefore, it is relevant to elucidate today's decision making process in order to find and initiate ways of improvement.

The cooperation between patients and health care professionals has undergone substantial development. Recent research within the area indicates that patients require more information on their disease and wish to participate more actively in decisions to be made. Consequently, the health care system has high focus on ”shared decision making” . The concept includes cooperation between patient and health care professionals enabling shared decision making based on patient values and preferences, and available scientific data must also be considered. The latest results of research within the area shows that patients taking actively part in the caring for their own health experience better results of their treatment than patients passively receiving health care. Internationally as well as in the national plans for patient involvement, shared decision making is considered both an essential aspect of improving the health care quality and a good basis for the patients, when they are to make difficult decisions. 

Several studies point to various indicators affecting the decision making process in relation to participation in clinical studies within oncology. These may by facilitators or barriers of shared decision making caused by the patient, relatives, doctors, nurses, or organizational aspects.  

Several tools have been developed internationally to support the decision making process, but it is a prerequisite for implementing them that the work method of the individual department is taken into account as well as the experience made by patients.  Further knowledge within the field is required to implement shared decision making which should be a goal to ensure that participation in a clinical trial is always based on the patient's active, personal decision.


The purpose of the study is to investigate factors characterizing the communication leading to acceptance or refusal to participation in clinical trials in oncology, including elucidation of:

  • The context of the decision making process.
  • Experiences and preferences of patients and relatives in the process of deciding whether or not to participate in a clinical trial.

Description of the cohort

Patients with advanced cancer

  • Doctors
  • Nurses

Data and biological material

  • Observations
  • Interviews