Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer.
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ABSTRACT: Objective
To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.Methods
Postmenopausal women, age 46-74, with BCRAT 5-year risk ? 1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n=690), Time 1 control (n=160), or 3-month control (n=162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women's decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.Results
Intervention participants had significantly lower decisional conflict levels at post-test (p<0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p<0.001) compared to control participants.Conclusion
GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.Practice implications
Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients' decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.
SUBMITTER: Banegas MP
PROVIDER: S-EPMC3650477 | biostudies-literature | 2013 Jun
REPOSITORIES: biostudies-literature
Publications
Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer.
Banegas Matthew P MP McClure Jennifer B JB Barlow William E WE Ubel Peter A PA Smith Dylan M DM Zikmund-Fisher Brian J BJ Greene Sarah M SM Fagerlin Angela A
Patient education and counseling 20130208 3
<h4>Objective</h4>To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.<h4>Methods</h4>Postmenopausal women, age 46-74, with BCRAT 5-year risk ≥ 1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n=690), Time 1 control (n=160), or 3-month control (n=162). Intervention participants viewed GtD prior to completing a post-test ...[more]
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Project description:BACKGROUND:Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE:The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS:We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS:Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as M?ori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for M?ori and 0.76 (95% CI -5.57 to 7.09) for non-M?ori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for M?ori and 1.36 (-3.16 to 5.88) for non-M?ori. No study-related adverse events were reported. CONCLUSIONS:The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous M?ori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).
| S-EPMC6858022 | biostudies-literature
Project description:BackgroundChemopreventive agents such as selective estrogen receptor modulators and aromatase inhibitors have proven efficacy in reducing breast cancer risk by 41% to 79% in high-risk women. Women at high risk of developing breast cancer face the complex decision of whether to take selective estrogen receptor modulators or aromatase inhibitors for breast cancer chemoprevention. RealRisks is a patient-centered, web-based decision aid (DA) designed to promote the understanding of breast cancer risk and to engage diverse women in planning a preference-sensitive course of decision making about taking chemoprevention.ObjectiveThis study aims to understand the perceptions of women at high risk of developing breast cancer regarding their experience with using RealRisks-a DA designed to promote the uptake of breast cancer chemoprevention-and to understand their information needs.MethodsWe completed enrollment to a randomized controlled trial among 300 racially and ethnically diverse women at high risk of breast cancer who were assigned to standard educational materials alone or such materials in combination with RealRisks. We conducted semistructured interviews with a subset of 21 high-risk women enrolled in the intervention arm of the randomized controlled trial who initially accessed the tool (on average, 1 year earlier) to understand how they interacted with the tool. All interviews were audio recorded, transcribed verbatim, and compared with digital audio recordings to ensure the accuracy of the content. We used content analysis to generate themes.ResultsThe mean age of the 21 participants was 58.5 (SD 10.1) years. The participants were 5% (1/21) Asian, 24% (5/21) Black or African American, and 71% (15/21) White; 10% (2/21) of participants were Hispanic or Latina. All participants reported using RealRisks after being granted access to the DA. In total, 4 overarching themes emerged from the qualitative analyses: the acceptability of the intervention, specifically endorsed elements of the DA, recommendations for improvements, and information needs. All women found RealRisks to be acceptable and considered it to be helpful (21/21, 100%). Most women (13/21, 62%) reported that RealRisks was easy to navigate, user-friendly, and easily accessible on the web. The majority of women (18/21, 86%) felt that RealRisks improved their knowledge about breast cancer risk and chemoprevention options and that RealRisks informed their (17/21, 81%) decision about whether or not to take chemoprevention. Some women (9/21, 43%) shared recommendations for improvements, as they wanted more tailoring based on user characteristics, felt that the DA was targeting a narrow population of Hispanic or Latina by using graphic novel-style narratives, wanted more understandable terminology, and felt that the tool placed a strong emphasis on chemoprevention drugs.ConclusionsThis qualitative study demonstrated the acceptability of the RealRisks web-based DA among a diverse group of high-risk women, who provided some recommendations for improvement.
| S-EPMC8262666 | biostudies-literature
Project description:BackgroundChemoprevention using selective estrogen receptor modulators and aromatase inhibitors has been shown to reduce invasive breast cancer incidence in high-risk women. Despite this evidence, few high-risk women who are eligible for chemoprevention utilize it as a risk-reducing strategy. Reasons for low uptake include inadequate knowledge about chemoprevention among patients and healthcare providers, concerns about side effects, time constraints during the clinical encounter, and competing comorbidities.Methods/designWe describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer. The trial is being conducted at a large, urban medical center. A total of 300 patients and 50 healthcare providers will be recruited and randomized to standard educational materials alone or in combination with the decision support tools. Patient reported outcomes will be assessed at baseline, one and six months after randomization, and after their clinic visit with their healthcare provider.DiscussionWe are conducting this trial to provide evidence on how best to support personalized breast cancer risk assessment and informed and shared decision-making for chemoprevention. We propose to integrate the decision support tools into clinical workflow, which can potentially expand quality decision-making and chemoprevention uptake.Trial registrationNCT03069742.
| S-EPMC6722284 | biostudies-literature
Project description:ImportanceTubal sterilization is common, especially among individuals with low income. There is substantial misunderstanding about sterilization among those who have undergone the procedure, suggesting suboptimal decision-making about a method that permanently ends reproductive capacity.ObjectiveTo test the efficacy of a web-based decision aid for improving tubal sterilization decision quality.Design, setting, and participantsThis randomized clinical trial conducted between March 2020 and November 2023 included English- or Spanish-speaking pregnant cisgender women aged 21 to 45 years who had Medicaid insurance and were contemplating tubal sterilization after delivery. Participants were recruited from outpatient obstetric clinics in 3 US cities.InterventionParticipants were randomized 1:1 to usual care (control arm) or to usual care plus a web-based decision aid (MyDecision/MiDecisión) (intervention arm). The aid includes written, audio, and video information about tubal sterilization procedures; an interactive table comparing contraceptive options; values-clarifying exercises; knowledge checks; and a summary report.Main outcomes and measuresThe co-primary outcomes were tubal sterilization knowledge and decisional conflict regarding the contraceptive decision. Knowledge was measured as the percentage of correct responses to 10 true-false items. Decisional conflict was measured using the low-literacy Decision Conflict Scale, with lower scores on a range from 0 to 100 indicating less conflict.ResultsAmong the 350 participants, mean (SD) age was 29.7 (5.1) years. Compared with the usual care group, participants randomized to the decision aid had significantly higher tubal sterilization knowledge (mean [SD] proportion of questions answered correctly, 76.5% [16.9%] vs 55.6% [22.6%]; P < .001) and lower decisional conflict scores (mean [SD], 12.7 [16.6] vs 18.7 [20.8] points; P = .002). The greatest knowledge differences between the 2 groups were for items about permanence, with more participants in the intervention arm answering correctly that tubal sterilization is not easily reversible (90.1% vs 39.3%; odds ratio [OR], 14.2 [95% CI, 7.9-25.4]; P < .001) and that the tubes do not spontaneously "come untied" (86.6% vs 33.7%; OR, 13.0 [95% CI, 7.6-22.4]; P < .001).Conclusions and relevanceMyDecision/MiDecisión significantly improved tubal sterilization decision-making quality compared with usual care only. This scalable decision aid can be implemented into clinical practice to supplement practitioner counseling. These results are particularly important given the recent increase in demand for permanent contraception after the US Supreme Court decision overturning federal abortion protections.Trial registrationClinicalTrials.gov Identifier: NCT04097717.
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Project description:BACKGROUND:Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis. METHODS AND FINDINGS:In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ? 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence. CONCLUSIONS:An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02319525.
| S-EPMC6505936 | biostudies-literature
Project description:INTRODUCTION:Chemotherapy may cause infertility in young survivors of breast cancer. Various fertility preservation techniques increase the likelihood of survivors becoming genetic mothers. Disclosure of cancer diagnosis may impact decision making about fertility preservation. This protocol will develop and test the effectiveness of a web-based decision aid for helping women with breast cancer to make well-informed choices about fertility preservation. METHODS AND ANALYSIS:This study will be conducted in three phases using mixed methods. In phase I, the aim is to develop a web-based patient decision aid (PDA) in French with a steering committee and using a focus group of five women already treated for breast cancer. In phase II, the face validity of the decision aid will be assessed using questionnaires. In phase III, the PDA will be assessed by a two-arm randomised controlled trial. This will involve a quantitative evaluation of the PDA in clinical practice comparing the quality of the decision-making process between usual care and the PDA. The primary outcome will be informed choice and its components. The secondary outcomes will be decisional conflict and anxiety. Data will be collected during and after an oncofertility consultation. Phase III is underway. Since September 2018, 52 participants have been enrolled in the study and have completed the survey. We expect to have results by February 2020 for a total of 186 patients. ETHICS AND DISSEMINATION:This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings. TRIAL REGISTRATION NUMBER:The ClinicalTrials.gov registry .(NCT03591848).
| S-EPMC7044978 | biostudies-literature
Project description:Background:Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective:To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design:Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061). Setting:13 medical and surgical ICUs at 5 hospitals. Participants:Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention:A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements:The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results:The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation:Contamination among clinicians could have biased results toward the null hypothesis. Conclusion:A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary Funding Source:National Institutes of Health.
| S-EPMC7363113 | biostudies-literature
Project description: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
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Project description:BACKGROUND:Most 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. METHODS:A 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. DISCUSSION:This 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 REGISTRATION:This study is retrospectively registered at ClinicalTrials.gov ( NCT03791138 ).
| S-EPMC6701008 | biostudies-literature
Project description:BACKGROUND: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. METHODS: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). RESULTS: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. CONCLUSIONS: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.
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