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Improving Informed Consent: A Randomised Controlled Trial of a Decision Aid for Women Invited to Participate in a Breast Cancer Prevention Trial (IBIS-2)
Background: Decision aids (DAs) present evidence-based information in a simple, graphical form, and lead patients through a process of clarifying their values. Meta-analyses have indicated that DAs improve decision-making in a number of treatment scenarios; however DAs have not been explored in relation to clinical trials (CTs). We have developed a DA to assist women to decide whether to join a breast cancer prevention trial (IBIS-2). IBIS-2 evaluates the role of anastrozole in the management of 2 groups of postmenopausal women at increased risk of breast cancer: 1) those recently treated for Ductal Carcinoma in Situ and 2) those with a family history of breast cancer.
Specific aims: This study aims to evaluate the effectiveness of a DA in assisting women to reach an informed decision about participation in IBIS-2.
Hypotheses: 1. Women receiving the DA versus no DA are expected to have: better understanding of treatment options and CTs, choices more concordant with their values, reduced decisional conflict, greater satisfaction with care and no greater anxiety.
2. Clinician-recruiters provided with the DA will have enhanced satisfaction with the informed consent and trial decision making process.
Study design: Using a block randomized trial design, the effect of provision of the DA versus no DA will be investigated in 400 women eligible to participate in IBIS-2. Blocks of 10 women will be randomized to the intervention or control group to reduce potential contamination between the arms. IBIS-2 recruiters will be trained in the optimal use of the DA. The recruiter will invite the woman to participate in the DA trial. In the intervention condition, recruiters will use the DA during the consent interview and encourage women to take the DA booklet home. Controls will undergo a standard consent process without reference to the DA. De-identified demographic and disease data on the refusers will be provided to the research team at the end of the study, to assess sample bias. Participants in the DA trial will be posted questionnaires 2 and 4 weeks after reaching their decision to participate or not in the IBIS-2 trial, to assess their understanding of and attitudes to the IBIS-2 trial and trials in general, their anxiety, the degree of conflict they experienced in reaching a decision, their current satisfaction with that decision, and their participation status.
Potential outcomes and benefits of the research: The current study has the potential to revolutionize the process of gaining informed consent in CTs.
Background: Before deciding whether to participate in a clinical trial, patients need clear, unbiased evidence-based information. However, clinicians often find this difficult to adequately provide. Decision aids (DAs) have been shown to be effective in improving the decision-making process, however, most existing DAs deal with standard treatment options and none have been evaluated in the context of a clinical trial. This project will evaluate whether a DA assists women in deciding whether or not to join a hormone prevention trial (IBIS-2). The IBIS-2 clinical trial investigates the effectiveness of anti-estrogen medications in reducing the risk of developing breast cancer. The DA presents information in a clear graphical form and leads the patients through a process of weighing up the pros and cons of the options.
Hypotheses: 1. Patients who receive the DA, versus those who do not, are expected to be: better informed about treatment options and clinical trials; able to decide more easily about participation in the trial; no more anxious; more satisfied with their care; and able to make decisions more concordant with their values.
2. Clinicians who recruit using the DA will be more satisfied with the informed consent and trial decision making process.
Specific aims: This study aims to evaluate the effectiveness of a DA in assisting women to reach an informed choice about participation in IBIS-2.
Study design: The DA study will consist of 2 groups of postmenopausal women, who will be invited to join the IBIS-2 trial: 1) those treated for Ductal Carcinoma in Situ, and 2) those with a family history of breast cancer. Groups of 10 women will be randomly assigned to be recruited using the DA, or no DA. Two and four weeks after reaching a decision about participation in IBIS-2, women who decide to participate in the DA trial will be posted questionnaires. These will assess their understanding of, and attitudes to, the IBIS-2 trial and trials in general; their anxiety; the difficulty of making the decision; and their satisfaction with the process of decision-making. Women’s actual decision (to participate or not) will also be recorded.
Potential outcomes and benefits of the research: This study has the potential to transform the process of informed consent by assisting patients to understand the purpose of clinical trials and make a decision about participation which is in accordance with their values and lives.