Dataset Information

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

ABSTRACT: Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

SUBMITTER: Hawley ST

PROVIDER: S-EPMC5946719 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

Hawley Sarah T ST Li Yun Y An Lawrence C LC Resnicow Kenneth K Janz Nancy K NK Sabel Michael S MS Ward Kevin C KC Fagerlin Angela A Morrow Monica M Jagsi Reshma R Hofer Timothy P TP Katz Steven J SJ

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20180124 7

Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patien ...[more]

PMID: 29364772

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Project description:The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.Random assignment to print-based decision aid (n?=?628), web-based interactive decision aid (n?=?625), or usual care (UC) (n?=?626).Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d?=?0.33) and print vs UC (d?=?0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P?=?.009) and significantly more web (P?=?.001) and print (P?=?.03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P?=?.06) and web participants (50.4%; P?=?.10) were not significant. Screening rates at 13 months did not differ significantly among groups.Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.clinicaltrials.gov Identifier: NCT00196807.

Project description:BackgroundOne in four Americans, and 70% of people who have dementia, will spend their final days in nursing home care. Clinical research, particularly clinical trials, rarely includes this population due to unique challenges in research methods and ethics. Families of advanced dementia patients make choices about tube feeding and other feeding options with limited access to information or communication. The cluster randomized trial, Improving Decision Making about Feeding Options for Dementia Patients, tests a decision aid intervention to improve the quality of decision making for this choice.PurposeOur objectives are (1) to describe the methods used in this trial; (2) to describe challenges and strategies for effective nursing home and nursing home resident recruitment and retention; and (3) to describe research ethics approaches to minimize harms and maximize benefits for this population.MethodsThe study is a cluster randomized trial of a decision aid to inform and support the choice between tube feeding and assisted oral feeding in advanced dementia. Study subjects are paired surrogate decision makers and residents with advanced dementia and feeding problems, enrolled from nursing homes in North Carolina.ResultsThis trial enrolled 256 paired surrogate decision makers and residents in 24 nursing home sites, and 99% completed participation through the 3-month study period. The research team had prior clinical and investigative experience in this setting, and used multiple strategies to recruit and retain nursing home sites, providers, surrogates, and the residents for whom they spoke. Informed consent and human subjects' protections were designed to address the vulnerability of this population.LimitationsCluster randomization was necessary to avoid contamination between control and intervention subjects, but may introduce confounding by site and intracluster correlation effects in analyses.ConclusionsStrategies that facilitate nursing home recruitment, participant recruitment and protection of human subjects for a vulnerable population may be used by future investigators to expand the research evidence base for nursing home and dementia care.

Project description:ImportanceLung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making.ObjectiveTo examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers.Design, setting, and participantsThis randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018.InterventionsParticipants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257).Main outcomes and measuresThe primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report.ResultsOf 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups.Conclusions and relevanceIn this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines.Trial registrationClinicalTrials.gov identifier: NCT02286713.

Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Project description:BackgroundLung cancer screening (LCS) is recommended for individuals at high risk due to age and smoking history after a shared decision-making conversation. However, little is known about best strategies for incorporating shared decision-making, especially in a busy primary care setting.ObjectiveTo develop a novel tool, Lung Cancer Assessment of Risk and Education (LungCARE) to guide LCS decisions among eligible primary care patients.DesignPilot cluster randomized controlled trial of LungCARE versus usual care.ParticipantsPatients of providers in a university primary care clinic, who met criteria for LCS.InterventionProviders were randomized to LungCARE intervention or control. LungCARE participants completed a computer tablet-based video assessment of lung cancer educational needs in the waiting room prior to a primary care visit. Patient and provider both received a summary handout of patient concerns and responses.Main measuresAll eligible patients completed baseline interviews by telephone. One week after the index visit, participants completed a follow-up telephone survey that assessed patient-physician discussion of LCS, referral to and scheduling of LCS, as well as LCS knowledge and acceptability of LungCARE. Two months after index visit, we reviewed patients' electronic health records (EHRs) for evidence of a shared decision-making conversation and referral to and receipt of LCS.Key resultsA total of 66 participants completed baseline and follow-up visits (34: LungCARE; 32: usual care). Mean age was 65.9 (± 6.0). Based on EHR review, compared to usual care, LungCARE participants were more likely to have discussed LCS with their physicians (56% vs 25%; p = 0.04) and to be referred to LCS (44% vs 13%; p < 0.02). Intervention participants were also more likely to complete LCS (32% vs 13%; p < 0.01) and had higher knowledge scores (mean score 6.5 (± 1.7) vs 5.5 (± 1.4; p < 0.01).ConclusionsLungCARE increased discussion, referral, and completion of LCS and improved LCS knowledge.Clinical trial registrationNCT03862001.

Dataset Information

Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

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Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

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