Navya-PPT May Help Patients With Early Breast Cancer Choose Between Breast-Conserving Surgery, Mastectomy

For early breast cancer, surgical treatment involves either mastectomy or breast conservation surgery and radiation. In addition, the rate of breast-conserving surgery drops in lower middle-income areas due to a lack of awareness and socioeconomic status. Although both surgery and radiation are effective forms of treatment, patients often have difficulties when making a decision. A study published in JAMA Network Open identified the impact of decision aid with a patient preference assessment tool for surgical decision-making, the Navya-Patient Preference Tool (Navya-PPT). The study also evaluated Navya-PPT’s impact on patients’ decisional conflict scale (DCS) scores.

The randomized clinical trial’s primary end point was the change in DCS score among women undergoing surgery for primary operable breast cancer after administering the Navya-PPT. A 16-item questionnaire was used to measure DCS score using a Likert scale from 1 (strongly agree) to 5 (strongly disagree), with higher scores reporting more conflict when making decisions.

The secondary end point measured the efficacy of the interventions on clinical outcomes, such as the breast-conserving surgery rates, concordance of Navya-PPT-reported preference with the final surgery received by the patient, and the effect of Navya-PPT on DCS score stratified by other psychological indices. Further, additional psychological scales—including the Autonomy Preference Index-Decision Making (API-DM), Traditional-Egalitarian Gender Roles (TEGR), and caregiving—were also measured using the 1 to 5 Likert scale.

A total of 245 adult patients with histologically proven early breast cancer (cT1-2, N0-1) who were eligible for breast-conserving surgery were randomized into 3 different study groups: standard care including clinical explanation about surgery (control), standard care plus the Navya-Patient Preference Tool (Navya-PPT) provided to the patient along (solo group) and standard care plus the Navya-PPT provided to the patient and a caregiver (joint group). The median age of the cohort was 48 years (range: 23-76), with 137 patients (55.9%) being premenopausal or perimenopausal. The median pathological tumor (pT) size was 2.5 (0-6) centimeters with 79 participants (32.2%) having pT less than or equal to 2 centimeters and 156 (63.7%) having pT greater than 2 centimeters. Further, axillary lymph node status on histopathology report was negative in 153 participants (62.4%), hormone receptor (estrogen receptor or progesterone receptor) status was positive in 185 (75.5%), and human epidermal growth factor receptor-2 was negative in 197 (80.4%).

The authors found that Navya-PPT may help patients with early breast cancer make the important decision between breast-conserving surgery and mastectomy. The findings demonstrate a significant reduction in DCS score in the solo group compared with the control group (1.34 versus 1.66, respectively; t163 = 3.19; 95% CI, 0.12-0.52; P < .001; Cohen d, 0.50; SD, 0.31).

In addition, the joint group showed reductions in comparison to the control group (1.31 versus 1.66, respectively; t160 = 3.42; 95% CI, 0.15-0.55; P < .001 Cohen d, 0.54; SD, 0.31). The study authors observed no significant differential effect of Navya-PPT on DCS score when stratified for TEGR and API-DM scores, and the interaction of caregiving role and Navya-PPT was insignificant (F1,241 = 3.73; P = .055 [analysis of variance]).

Further, the overall rate of breast conserving surgery was 82.4% (202 of 232 [87.1%] available surgical details) and was equal across the 3 groups. A total of 242 patients had expressed a preference for a specific type of surgery, with 169 (70%) requesting a lumpectomy, 37 (15%) requesting a mastectomy, and 36 (15%) noting they were unsure.

Of the 202 patients who received breast-conserving surgery, 30 had received a mastectomy, leading to a match percentage of 57.9% in the control group, 71.3% in the solo group, and 75.3% in the joint group; however, an analysis of patients’ preferences had indicated that a greater proportion of patients reported being unsure of their preference in the control group (18 of 79 [22.8%]) compared to patients in the solo group (8 of 83 [9.6%]), which is consistent with the control group’s higher DCS scores.

Although the joint group (10 of 80 [12.5%]) shared similarities with the solo group, the proportion of the control group to the joint group’s unsure patients were not significantly different from one another. The study authors noted that those who experienced surgery that matched their preference had also reported significantly lower DCS score compared with those whose preferences did not match (mean [SD], 1.32 [0.48] vs 1.71 [0.79]; F1,227 = 22.12; P < .001).

Limitations of the study include the lack of measurement of DCS score pre-randomization and the non-inclusion of specific quality of life parameters to document the benefits of intervention. Further, the study authors note that prior research indicated that female surgeons had influence on patients’ decision-making on breast-conserving surgery; however, the current study did not document the surgeons’ genders, therefore, there is no indication whether this had an influence on the patients’ decision-making.

Reference

Joshi S, Ramarajan L, Ramarajan N, et al. Effectiveness of a Decision Aid Plus Standard Care in Surgical Management Among Patients With Early Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(10):e2335941. doi:10.1001/jamanetworkopen.2023.35941