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Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.

ABSTRACT: Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.ClinicalTrials.gov: NCT00967824

SUBMITTER: Korfage IJ

PROVIDER: S-EPMC3978729 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.

Korfage Ida J IJ Fuhrel-Forbis Andrea A Ubel Peter A PA Zikmund-Fisher Brian J BJ Greene Sarah M SM McClure Jennifer B JB Smith Dylan M DM Alford Sharon Hensley SH Fagerlin Angela A

Breast cancer research : BCR 20130101 5

<h4>Introduction</h4>Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.<h4>Methods</h4>We ...[more]

PMID: 24004815

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Project description:BackgroundDecision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.ObjectiveTo determine whether a decision aid increases informed choice about mammography screening programme participation.MethodsA representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and χ2-tests.Results1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.ConclusionThis paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.Trial registrationGerman Clinical Trials Register DRKS00005176.

Project description:BackgroundMost breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness.MethodsA multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs.DiscussionThis study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision.Trial registrationThis study is retrospectively registered at ClinicalTrials.gov ( NCT03791138 ).

Project description:BackgroundAn Internet safety decision aid was developed to help abused women understand their risk for repeat and near-lethal intimate partner violence, clarify priorities related to safety, and develop an action plan customized to these priorities.PurposeTo test the effectiveness of a safety decision aid compared with usual safety planning (control) delivered through a secure website, using a multistate RCT design. The paper evaluates the effectiveness of the safety decision aid in reducing decisional conflict after a single use by abused women.DesignRCT referred to as Internet Resource for Intervention and Safety (IRIS).Setting/participantsAbused women who spoke English (n=708) were enrolled in a four-state RCT.InterventionThe intervention was an interactive safety decision aid with personalized safety plan; the control condition was usual safety planning resources. Both were delivered to participants through the secure study website.Main outcome measuresThis paper compares women's decisional conflict about safety: total decisional conflict and the four subscales of this measure (feeling: uninformed, uncertain, unsupported, and unclear about safety priorities) between intervention/control conditions. Data were collected from March 2011 to May 2013 and analyzed from January to March 2014.ResultsImmediately following the first use of the interactive safety decision aid, intervention women had significantly lower total decisional conflict than control women, controlling for baseline value of decisional conflict (p=0.002, effect size=0.12). After controlling for baseline values, the safety decision aid group had significantly greater reduction in feeling uncertain (p=0.006, effect size=0.07) and in feeling unsupported (p=0.008, effect size=0.07) about safety than the usual safety planning group.ConclusionsAbused women randomized to the safety decision aid reported less decisional conflict about their safety in the abusive intimate relationship after one use compared to women randomized to the usual safety planning condition.

Project description:BACKGROUND:Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied. OBJECTIVE:In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process. METHODS:In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease. RESULTS:This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events. CONCLUSIONS:This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions.

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Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.

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Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.

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