A Psychosocial Approach to Understanding Causality Assessment in Early Phase Oncology Clinical Trials: A Phenomenological Study

Research Question: What are the psychosocial factors that affect causality assessment in early phase oncology clinical trials? Methods: Thirty-two qualitative interviews were explicated with the aid of “Naturalistic Decision Making”. Data explication consisted of phenomenological reduction, delineating and clustering meaning units, forming themes, and creating a composite summary. Participants were members of the National Cancer Institute of Canada’s Clinical Trial Group Investigative New Drug committee. Results: The process of assigning causality is extremely subjective and full of uncertainty. Physicians had no formal training, nor a tool to assist them with this process. Physicians were apprehensive about their decisions and felt pressure from their patients, as well as the pharmaceutical companies sponsoring the trial. Conclusions: There are many problem areas when attributing causality, all of which have serious consequences, but clinicians used a variety of methods to cope with these problem areas.

Name thesis:degree_name

M.A. Applied Health Sciences

Level thesis:degree_level

Masters

Discipline thesis:degree_discipline

Faculty of Applied Health Sciences

Department dc:contributor.department

Applied Health Sciences Program

Grantor

Brock University

Year dc:date.issued

2011

Author dc:creator

• Torti, Jacqueline

• Psychosocial
• Oncology
• Causality
• Decision-Making
• Phenomenology

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/10464/3400

OAI identifier oai:identifier

oai:brocku.scholaris.ca:10464/3400