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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:IntroductionMaintaining and enhancing vaccine confidence continues to be a challenge. Making an informed decision not only helps to avoid potential future regret but also reduces susceptibility to misinformation. There is an urgent need for interventions that facilitate informed decision-making about vaccines. This paper describes the systematic development of two interventions designed to promote informed decision making and indirectly, acceptance of maternal pertussis vaccination (MPV) in the Netherlands.Materials and methodsThe 6-step Intervention Mapping (IM) protocol was used for the development of an online tailored decision aid and Centering Pregnancy-based Group Antenatal Care (CP) intervention. A needs assessment was done using empirical literature and conducting a survey and focus groups (1), intervention objectives were formulated at the behavior and determinants levels (2), theoretical methods of behavior change were selected and translated into practical applications (3), which were further developed into the two interventions using user-centered design (4). Finally, plans were developed for implementation (5), and evaluation (6) of the interventions.ResultsThe needs assessment showed that pregnant women often based their decision about MPV on information sourced online and conversations with their partners, obstetric care providers, and peers. Responding to these findings, we systematically developed two interactive, theory-based interventions. We created an online tailored decision aid, subjecting it to four iterations of testing among pregnant women, including those with low literacy levels. Participants evaluated prototypes of the intervention positively on relevance and usability. In addition, a CP intervention was developed with midwives.ConclusionUsing IM resulted in the creation of an online decision aid and CP intervention to promote informed decision making regarding MPV. This description of the systematic development of the interventions not only serves to illustrate design rationales, it will also aid the interpretation of the evaluation of the interventions, the development of future interventions promoting informed decision and acceptance of vaccines, and comparisons with other interventions.

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.

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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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