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abstract:
Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer
Highlights
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- We focus on adequacy of consent information in enabling informed trial decisions.
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- Choices were made in context of illness management, not ‘research participation’ alone.
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- There was little evidence of active reasoning between trial participation and standard care.
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- Trial information should support informed decision between trial participation and standard care.
Abstract
Background
Research
governance requires patients give informed consent to participate in
clinical trials. However, there are concerns that consent information
may not support patient participation decisions. This study investigates
the utility of consent information in supporting women’s trial
participation decisions when receiving treatment for cancer.
Design
An
interview study with women receiving cancer treatments at a medical
oncology outpatient clinic in Yorkshire (UK). All women over 18 years,
not admitted to a hospital ward and who had currently or previously been
invited to take part in a trial were invited to take part in the study
over a three month period. Interviews were audio-tape recorded,
transcribed and analysed using thematic analysis.
Results
Of those eligible (n = 41), 21 women with breast (n = 11), ovarian (n = 8) and endometrial (n = 2)
cancer participated (mean age = 57 years). Eighteen had made at least
one trial decision and three were considering taking part in a trial.
Findings are synthesised under two analytical themes: 1) Influence of
the cancer and cancer treatment context on decision making for trial
participation; and 2) Experiences of the consenting process and their
influence on decision making.
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