Interventions supporting cancer patients in making decisions regarding participation in clinical trials - a systematic review.

OBJECTIVES: Existing research on the perspectives of patients with cancer and health care professionals indicates that patient decision making on cancer clinical trial participation is a complex process and may be poorly understood, possibly compromising their decision to participate. This systematic review investigates interventions that support patients in their decision-making processes regarding whether to participate or not and assesses the qualities of the interventions, measures used and related outcomes. METHODS: Six databases were systematically searched and only studies evaluating interventions that support the decision making of adult patients offered to enter a cancer clinical trial were included. Ten articles met the criteria and were analysed using a narrative synthesis approach. RESULTS: The research focus of the included studies reflected the multifactorial nature of what constitutes support for patient decision making in terms of entering a cancer clinical trial. However, most interventions were based on the hypothesis that more information leads to support in decision making, and did not take other factors, such as the relationship to the clinical staff or relatives, the patients' strong hope for therapeutic benefit or other existential needs into account. The interventions were primarily based on a specific tool, executed once, which seems to imply that decisions need only to be supported once and not at several time points throughout the decision process, and did not assess the importance of a patient's family- or social relations. Moreover, few interventions focused on the patients' counselling experience or assessed patient preferences in relation to decision making. CONCLUSIONS: The findings demonstrate a lack of research on interventions to support patients' decision making that takes other factors, apart from improving knowledge of trials, into account. Limited evidence exists on the effectiveness of decision support interventions to improve the experience of support in adult patients with cancer. Interventions that take patient preferences in relation to decision making and the social context of decision processes into account need to be developed and assessed.

Cancer patients' perceptions of factors influencing their decisions on participation in clinical drug trials: A qualitative meta-synthesis.

AIMS AND OBJECTIVES: To examine cancer patients' perceptions of factors that may influence their decisions on participating in phase I-III clinical drug trials. BACKGROUND: The number of cancer participants in clinical drug trials has increased rapidly in Denmark in recent years. The rights, safety and well-being of patients considering participation are protected by the international, ethical and scientific principles. A meta-synthesis was conducted to enable health professionals to support cancer patients who are considering trial participation in accordance with the above principles. DESIGN: Meta-synthesis. METHODS: A qualitative meta-synthesis, as described by Sandelowski and Barroso, was conducted based on a literature search in PubMed, CINAHL, EMBASE and PsycINFO. Nine reports were found eligible and were included. The PRISMA checklist was used. RESULTS: A framework was developed, and patients' perceptions of the factors influencing their decisions were identified, namely patients' perceptions of their relatives, the physician, the hope of therapeutic benefit, altruism, having other options and living with cancer. CONCLUSIONS: This study shows that cancer patients' decisions on participation in clinical drug trials are influenced by their perceptions of trust towards the physician, their relatives' attitudes and the consequences participation might have for their families. Patients are motivated to participate due to the hope of therapeutic benefit and for altruistic reasons. The factors influencing their decisions to participate include a cost-benefit consideration, which in turn may be subject to the patient's perception of having other options available besides participation. This may be related to the patient's attitude towards living with cancer, and the decision can be a way of trying to cope with the psychological aspects of living with cancer. RELEVANCE TO CLINICAL PRACTICE: The results of this meta-synthesis offer insight into patients' perceptions of what may influence their decisions, and they enable health professionals to support patients making such decisions.

When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges.

This study investigated the kinds of ethical challenges experienced by nurses in oncology and hematology when nursing care and research overlap in clinical trials, and how the nurses handle such challenges. Individual interviews with 39 nurses from Sweden, Denmark, and Finland indicated that all nurses were positive about research, considering it essential for developing the best care. Ethical challenges exist, however; the most difficult were associated with the end-of-life patients, no longer responsive to standard therapy, who eagerly volunteer for cutting-edge drug trials in the hope of gaining therapeutic benefit. Many nurses lacked systematic strategies for addressing such challenges but found support from their nursing colleagues and relied on the research protocols to guide them.