Background: Women with early breast cancer routinely face a choice between breast conservation therapy and mastectomy, and assume agency through shared decision making. However, for women with lower socioeconomic power or education, barriers such as access to understandable information, involvement of family in decision making, and a decreased sense of autonomy inhibits this agency. To better empower this population, a simple to understand, online, self-administered, conjoint analysis based decision aid called “Navya Patient Preference Tool” (PPT) is developed to be used outside the physician encounter. PPT is unique in its incorporation of several psychological scales that assess potential confounders of participation in shared decision making. Methodology: This is a pre-planned analysis of the reliability and validity of the psychological scales used in all three arms of an IRB approved randomized controlled trial to assess PPT. Women with operable node negative breast cancer eligible for BCT or MRM at one of Asia's largest academic tertiary cancer centers were eligible. PPT trial consists of an initial conjoint analysis questionnaire analyzing implicit preferences for breast conservation given to the intervention arms. The following psychological scales were given to all patients regardless of randomization: Autonomy Preference Index (API), Traditional-Egalitarian Gender Roles (TEGR), Caregiving Role, Brief Resiliency Scale (BRS), Appearances Scale, and Decisional Conflict Scale (DCS). Cronbach's alpha as a measure of internal reliability for all scales, and correlations of scores with known demographic trends as a measure of external validity are calculated. Results: Of the 102 patients enrolled, 30 completed PPT in English, 39 in Hindi, and 33 in Marathi, (vernaculars). 69/102 were in middle and lower socioeconomic groups (Kuppuswamy Index). 53/102 had completed less than high school education. Internal reliability of all scales were high, with Cronbach's alpha above 0.7: API 0.74, TEGR 0.78, Caregiving 0.7, BRS 0.7, Appearance 0.84. DCS was highly reliable at 0.91, and is the primary outcome measure for the RCT. Correlations in the dataset met those expected in real world data, suggesting external validity. For e.g., education was inversely correlated with traditional gender roles on TEGR (R -0.4, p <0.01), and positively correlated with resilience on BRS (R 0.228, p <0.05). Individual scale items that are unrealistic were not chosen by any of the 102 respondents (e.g.,. My doctor should not participate in my medical decisions), substantiating nuanced reading. 85% of patients “Strongly Agreed” on a 1-5 Likert scale that “The survey questions were easy to understand” (mean score 1.18/5. SD 0.4). Conclusions: Women with limited education and low socioeconomic status complete the online, self administered PPT outside of a physician encounter, with high internal reliability and external validity. Decision Aids such as Navya PPT, which account for psychosocial confounders of agency, have the potential to benefit women otherwise marginalized from shared decision making. Citation Format: Joshi S, Ramarajan L, Ramarajan N, Srivastava G, Begum F, Deshpande O, Tondare A, Nair N, Parmar V, Gupta S, Badwe RA. Accuracy of psychosocial assessments in an online surgical decision aid developed for early breast cancer patients with resource and educational constraints [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-14-07.
7033 Background: Shared decision making to confront choices with clinical equipoise, has been the privilege of those patients with access to time intensive consults with oncologists. We conducted a randomized controlled trial for breast cancer patients to use an online, self-administered, out-of-the-medical-encounter decision aid (DA) to choose between breast conserving surgery (BCS) and mastectomy. Methods: Navya Patient Preference Tool (Navya PPT) is a multilingual DA based on adaptive conjoint analysis of tradeoffs between cost, adverse effects of radiation, and breast conservation. Prior analysis established high internal reliability and external validity of the Navya PPT. Eligible cT1/2, cN0 breast cancer patients planned for surgery were block randomized, in 1:1:1 ratio, to receive the research questionnaire (RQ) to measure decisional conflict on choice of surgery (control, arm 1), Navya PPT followed by RQ (experimental, arm 2) or Navya PPT followed by RQ administered with key male family member (experimental, arm 3). Groups were stratified with respect to age, socio-economic status (SES) and educational level. The study was powered to detect a decrease in Decisional Conflict Index (DCI) by 0.25 (β-0.8, two sided α- 0.01). Results: Between June 2017 and December 2019, 247/255 patients were randomized to arm 1 (83), arm 2 (84), and arm 3 (80). Median age was 48 years (IQR 23-76), and median pT size was .5 cm (0.5-6 cm). 59% of patients were middle or lower SES and 46.2% had ≤ 12th grade education. DCI was significantly reduced in arm 2 as compared with arm 1 (1.34 vs. 1.65, Cohen’s d 0.49 (± 0.31) p<0.05) as well as in arm 3 as compared with arm 1 (1.30 vs. 1.65, Cohen’s d 0.54 (± 0.31) p<0.05). 80% (± 6%) of patients underwent surgery of choice as determined by Navya PPT. BCS rate was similar in all three arms (85.2, 88.9 and 86.5% respectively (p=0.779). Conclusions: Online, self-administered, adaptive DAs used out of the medical encounter can reduce decisional conflict and increase access to shared decision making for every patient; especially in practices with low doctor to patient ratios. Clinical trial information: IEC/0116/1619/001 .
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