Facilitating decision-making in women undergoing genetic testing for hereditary breast cancer: BRECONDA randomized controlled trial results

6500 Background: High quality treatment decisions require that patients are well informed about treatment and that their values are considered. Yet studies show that patient knowledge about breast cancer treatment trade-offs is low and appraisal of decision-making is not optimal. Methods: We conducted a randomized controlled trial (RCT) of a tailored, comprehensive (locoregional and systemic treatment) and interactive decision tool (iCanDecide), compared with static online information. 537 newly diagnosed, early stage breast cancer patients were enrolled at the first visit in 22 surgical practices. Participants were surveyed 5 weeks (N = 496; RR 92%) post enrollment after locoregional treatment decision-making. The primary outcome was a high quality decision, including two components: high knowledge about treatment options and a values concordant treatment decision. The main secondary outcome was preparation for decision making. We evaluated the distribution of participants in each arm, and conducted logistic regression modeling to assess the association between the intervention and the outcomes controlling for patient characteristics and strength of treatment preference at enrollment. Results: Significantly more intervention than control patients had high knowledge (60% vs. 42%, p < 0.001), although the majority of both groups reported values concordant treatment (~84%). Intervention patients also reported feeling prepared for decision making significantly more often than controls (45% vs. 32%, P < 0.01). Patients randomized to the interactive intervention had higher knowledge (OR: 2.2; 95% CI 1.2-4.0) and preparation for decision making (OR: 1.5; 95% CI 1.1-1.4), even after adjusting for age, education, race, stage and clinical site. Conclusions: In this large RCT, a tailored, interactive treatment decision tool for breast cancer improved knowledge and prepared patients for complicated decision making, more than access to static online information. Future work to further integrate such tools into the clinical workflow is needed. Clinical trial information: NCT01840163.

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A randomized controlled trial of a self-administered, online decision-aid (“Navya Patient Preference Tool”) to reduce decisional conflict in women with early breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.7033 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 7033-7033

Author(s):

Shalaka P Joshi ◽

Lakshmi Ramarajan ◽

Ojas Deshpande ◽

Elizabeth Fernandes ◽

Vaibhav Vanmali ◽

...

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Randomized Controlled Trial ◽

Decision Aid ◽

Controlled Trial ◽

Decisional Conflict ◽

Shared Decision ◽

Breast Cancer Patients ◽

Medical Encounter ◽

Randomized Controlled

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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