Factors associated with participation in phase 1 and phase 3 oncology trials
Format
Funding
The Swedish Cancer Society (Cancerfonden)Time table
2010-2012
Aims
The aim of this project is to understand on what premises Swedish patients decide to participate in phase 1 and phase 3 oncology trials with emphasis on their attitudes regarding risk, own benefits and benefits for future patients. We will also investigate the implications of this understanding for information and consent procedures used when recruiting patients to such trials.
There is a lack of both philosophical analysis and empirical support of for patients views to guide the selection of appropriate information and consent procedures for patients with progressive cancer.
A common conception is that patients participate in order to reap benefits of their own, while the scientific objective is to benefit future patients, i.e. the therapeutic misconception. However, the concept of benefit is complex and there are different ways patients may perceive their participation. There is a need of empirical studies that focus specifically on the balancing of benefits and risks, the issue of voluntariness and the role of doctors and research associates in promoting patient autonomy for clinical cancer trials. In particular, there is a lack of information on these issues from the perspective of the Swedish health care system and how Swedish patients reason.
In this project we want to find answers to the following questions:
- How do cancer patients participating in phase 1 and phase 3 clinical trials perceive their participation with regard to risk, benefits (own and for future patients) and information?
- What is their perception of the role of physicians and clinical research associates with regard to recommendations to participate, success of information transfer, time assigned for making decision?
- Do they regard their participation as voluntary and on what conditions would they like to withdraw?
- Is willingness to participate related to patients’ quality of life?
- How may the risk of treatment/therapy misconception be handled in association with randomized controlled clinical cancer trials?
The project consists of two parts: interviews with phase 1 trial participants and, using the results from these interviews, a questionnaire to patients who participate in phase 3 trials.
More information
- Tove Godskesen, RN, PhD student
Supervisors
- Ulrik Kihlbom, PhD, Senior lecturer, CRB
- Karin Nordin, Professor, Department of Public Health and Caring Sciences, Co-Supervisor
- Peter Nygren, Professor, Department of Radiology, Oncology and Radiation Science, Co-Supervisor
The project group also includes
- Mats G. Hansson, Professor of biomedical ethics
- Anna T. Höglund, Associate professor of Ethics
- Sofia Kälvemark Sporrong, PhD, Associated researcher
Share |