Efficacy of a Decision Aid in Breast Cancer Patients Considering Immediate Reconstruction:Results of a Randomized Controlled Trial

Background: Breast cancer patients face complex decisions about immediate breast reconstruction (BR) after mastectomy. The authors evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality, and health outcomes in breast cancer patients considering immediate BR. Methods: In a multicenter, randomized, controlled trial, patients were allocated to either the intervention group, receiving care as usual with access to an online decision aid, or the control group, receiving care as usual with an information leaflet. The primary outcome was decisional conflict. Secondary outcomes assessed the process of decision-making (eg, preparation for decision-making, satisfaction with information), decision quality (decision regret, knowledge), and health outcomes (eg, satisfaction with BR outcomes, body image). Patients completed questionnaires at time (T) 0 (baseline); T1 (1 week after consultation with a plastic surgeon); and T2 (3 months) and T3 (12 months) after surgery. Results: The authors included 250 patients. Decisional conflict decreased over time in both groups, with no between-group differences. Intervention participants felt better prepared for decision-making than controls (P = 0.002). At T2, 87% of intervention participants were very satisfied with the information about BR, compared with 73% of control participants (P = 0.011). No significant between-group differences were observed in any other outcome. Conclusions: The authors’ online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. However, the decision aid substantially improved the decision-making process by better preparing breast cancer patients for decisions about immediate BR.</p

The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: Study protocol of a multicenter randomized controlled trial

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)

Efficacy of a decision aid in breast cancer patients considering immediate reconstruction: results of a randomized controlled trial

PURPOSE: Breast cancer patients face complex decisions about immediate breast reconstruction (BR) after mastectomy. We evaluated the efficacy of an online decision aid in improving the decision-making process, decision quality and health outcomes in breast cancer patients considering immediate BR. METHODS: In a multicenter randomized controlled trial, patients were allocated to either the intervention group receiving care-as-usual (CAU) with access to an online decision aid, or the control group receiving CAU with an information leaflet. The primary outcome was decisional conflict. Secondary outcomes assessed the process of decision making (e.g. preparation for decision making, satisfaction with information), decision quality (decision regret, knowledge) and health outcomes (e.g. satisfaction with BR outcomes, body image). Patients completed questionnaires at baseline (T0), 1 week after consultation with a plastic surgeon (T1), 3 months (T2), and 12 months post-surgery (T3). RESULTS: We included 250 patients. Decisional conflict decreased over time in both groups, with no between group differences. Intervention participants felt better prepared for decision making than controls (P = .002). At T2, 87% of intervention participants were (very) satisfied with the information about BR, compared to 73% of control participants (P = .011). No significant between group differences were observed in any other outcome. CONCLUSION: Our online decision aid was as effective in reducing decisional conflict as an information leaflet about immediate BR after mastectomy. However, the decision aid substantially improved the decision-making process by better preparing breast cancer patients for decisions about immediate BR

Decisional conflict in breast cancer patients considering immediate breast reconstruction

Background: Breast cancer (BC) patients who are treated with mastectomy are frequently offered immediate breast reconstruction. This study aimed to assess decisional conflict in patients considering immediate breast reconstruction, and to identify factors associated with clinically significant decisional conflict (CSDC). Methods: Baseline data of a multicenter randomized controlled trial evaluating the impact of an online decision aid for BC patients considering immediate breast reconstruction after mastectomy were analyzed. Participants completed questionnaires assessing sociodemographic and clinical characteristics, decisional conflict and other patient-reported outcomes related to decision-making such as breast reconstruction preference, knowledge, information resources used, preferred involvement in decision-making, information coping style, and anxiety. Multivariable logistic regression analysis was performed to identify factors associated with CSDC (score > 37.5 on decisional conflict). Results: Of the 250 participants, 68% experienced CSDC. Patients with a slight preference for breast reconstruction (odds ratio (OR) = 6.19, p < .01), with no preference for or against breast reconstruction (OR = 11.84, p < .01), and with a strong preference for no breast reconstruction (OR = 5.20, p < .05) were more likely to experience CSDC than patients with a strong preference for breast reconstruction. Furthermore, patients with more anxiety were more likely to experience CSDC (OR = 1.03, p = .01). Conclusion: A majority of BC patients who consider immediate breast reconstruction after mastectomy experience clinically significant decisional conflict. The findings emphasize the need for decision support, especially for patients who do not have a strong preference for breast reconstruction

Internal Mammary Artery Perforator Flap for Immediate Volume Replacement Following Wide Local Excision of Breast Cancer

Background Breast-conserving therapy is defined as a breast-conserving wide local excision (WLE) of a mammary tumour combined with postoperative radiotherapy. Immediate restoration of the mammary shape by use of breast reduction techniques (volume displacement) or tissue replacement techniques (volume replacement) is gaining popularity to prevent breast malformation. Methods To date, using the internal mammary artery perforator (IMAP) flap has been suggested for immediate volume replacement after WLE, but has never been evaluated in a published study. Results We applied this flap in 12 women (mean age, 56.1 years) after WLE (mean specimen weight, 46.5 g) of the medial aspect of the breast. Over a median follow-up of 35.3 months (standard deviation, 1.2 months), 4 women needed repeated surgery for dog-ear correction of the donor site. Conclusions In our experience, the use of an IMAP flap was a reliable technique with good cosmetic outcomes after oncoplastic reconstruction. In this series, donor site revision often proved necessary initially, but we showed that this may easily be prevented

Effect of latissimus dorsi flap breast reconstruction on the strength profile of the upper extremity

Abstract: Objective: Dissection of the latissimus dorsi (LD) flap may have a distinct impact on upper extremity function and strength. To date, insufficient differentiation has been made between loss of muscular strength and shoulder function by dissection of the LD muscle per se and loss of function resulting from all excisional surgery, radiation therapy, and reconstructive procedures at the donor site and the recipient site that may have been combined near the shoulder region. Methods: This study determines the long-term effect of the LD breast reconstruction on the strength profiles of the upper extremity by measuring the isometric torque strength both in seven synergistic- and two contra-movement directions. The Biodex System 3 Pro (Biodex Medical Systems, New York, NY) was used in 12 patients at a mean of 3.5 years after surgery, and in 20 matched controls. Because loss of LD muscle may not result in significant impairment of activities of daily live (ADL) even in cases where objective measurements are decreased, this study simultaneously assessed the subjective function by use of the standardised Disability of Arm, Shoulder and Hand (DASH) questionnaire. Results: This study observed a significant long-term loss of 8.8 Nm or 19% LD torque strength in synergistic movement directions after transplantation of the LD muscle. This loss correlated significantly with an increase of the mean DASH score among the patients. Conclusions: Because no significant loss of contra-movement torque strength was observed, it was concluded that the loss of synergistic torque strength appears to result from the loss of LD function per se