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Background: Neoadjuvant systemic therapy (NAST) is used for large operable or highly proliferative breast cancers. It is not known whether psychological outcomes differ according to the treatment sequence (chemotherapy or surgery first) or tumour response., Methods: This was a planned analysis of a multi-institutional single arm longitudinal study of patients considering NAST for operable breast cancer. Participants completed patient reported outcome questionnaires before and after the decision about NAST, between chemotherapy and surgery, and 12 months after diagnosis., Results: Fifty-nine women enrolled. Fourteen of 51 (28%) who received NAST experienced pathological complete response (pCR). Patients who had surgery first (n = 7) had higher baseline anxiety, and a greater decrease in anxiety at 12 months follow up, compared with patients who received NAST (n = 50) (a decrease from baseline of 34 pts vs 17 points; p = 0.033). Distress declined at a similar rate in surgery first and NAST groups. Mean satisfaction with decision score post-decision was significantly lower in the adjuvant group compared with NAST (22 vs 26, p = 0.02). No differences were seen between patients with pCR vs residual cancer in: distress, anxiety, satisfaction with decision, fear of progression, and decision regret., Conclusion: Most patients in this study proceeded with NAST when their surgeon offered it as an option. This exploratory analysis suggests that patients who chose surgery first tended to be more anxious, and had lower satisfaction with their decision, than those who had NAST. In patients who had NAST, lack of pCR does not appear to correlate with adverse psychological outcomes., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

The aim of this pilot study was to test the feasibility and acceptability of a family carer intervention for carers of patients with high-grade glioma (HGG). The intervention consisted of: (1) an initial telephone assessment of carer needs; (2) a personalised tabbed resource file; (3) nurse-led home visit; and (4) ongoing telephone support. Two consumer representatives reviewed the intervention resources. The intervention was then piloted with participants who were the primary carer for patients undergoing treatment for HGG in Western Australia. Two consumers provided feedback on the resource, and 10 carers participated in the pilot. Positive feedback was received about the resource manual and intervention. Suggestions were also made for changes which were implemented into the trial. The surveys were shortened based on feedback. Participants identified a large range of issues during nursing assessments which would not otherwise be identified or addressed for carers receiving routine care. As a result of providing the intervention, the nurse was able to make referrals to address needs that were identified. This pilot study enabled us to refine and test the Care-IS intervention and test the feasibility and acceptability of proposed survey instruments. We were also able to estimate recruitment and retention and the overall study timeline required for the randomised controlled trial we are now conducting. It has also demonstrated the role of the nurse who delivered the intervention and allowed us to refine communication and referral pathways.

Background: Neoadjuvant systemic therapy (NAST) is an increasingly used treatment option for women with large operable or highly proliferative breast cancer. With equivalent survival outcomes between NAST and up-front surgery, the situation-specific preference-sensitive nature of the decision makes it suitable for a decision aid (DA). This study aimed to develop and evaluate a DA for this population. Methods: A DA booklet was developed according to international standards, including information about adjuvant and neoadjuvant treatment, outcome probabilities, and a values clarification exercise. Eligible women, considered by investigators as candidates for NAST, were enrolled in a multi-institutional, single-arm, longitudinal study. Patient-reported outcome measure questionnaires were completed pre- and post-DA, between chemotherapy and surgery, and at 12 months. Outcomes were feasibility (percentage of eligible patients accessing the DA); acceptability to patients (percentage who would recommend it to others) and clinicians (percentage who would use the DA in routine practice); and decision-related outcomes. Results: From 77 eligible women, 59 were enrolled, of whom 47 (79.7%; 95% CI, 69.4-89.9) reported having read the DA; 51 completed the first post-DA questionnaire. Of these 51, 41 participants (80.4%; 95% CI, 69.5-91.3) found the DA useful for their decision about NAST. Of 18 responding investigators, 16 (88.9%; 95% CI, 74.4-103.4) indicated they would continue to use the DA in routine practice. Post-DA, decisional conflict decreased significantly ( P <.01); anxiety and distress decreased significantly; and 86.3% (95% CI, 73.7-94.3) achieved at least as much decisional control as they desired. Conclusions: This DA was feasible and acceptable to patients and clinicians, and improvement in decision-related outcomes was demonstrated when used in combination with clinical consultations. This DA could safely be implemented into routine practice for women considering NAST for operable breast cancer., (Copyright © 2018 by the National Comprehensive Cancer Network.)

Introduction: High-grade glioma (HGG) is a rapidly progressive and debilitating disease. Primary carers experience significant levels of distress which impacts on their experience of caregiving, the quality of care received and the community in terms of the increased reliance on healthcare due to the potential development of complicated grief. This paper describes the protocol for testing the efficacy and feasibility of an intervention for primary carers of patients with HGG in order to improve preparedness to care and reduce carer distress., Methods: Randomised controlled trial. The target population is carers of patients with HGG who are undergoing combined chemoradiotherapy. The intervention consists of 4 components: (1) initial telephone assessment of unmet needs of the carer, (2) tailoring of a personalised resource folder, (3) home visit, (4) ongoing monthly telephone contact and support for 12 months. The control arm will receive usual care., Primary Hypothesis: This intervention will improve preparedness for caring and reduce carer psychological distress., Secondary Hypothesis: This intervention will reduce carer unmet needs. The longer term aim of the intervention is to reduce patient healthcare resource utilisation and, by doing so, reduce costs. Assessments will be obtained at baseline, 8 weeks post intervention, then 4, 6 and 12 months. Participants will also complete a healthcare utilisation checklist and proxy performance status which will be assessed at baseline and monthly. 240 carers will be recruited. The sample size is 180. Multilevel mixed effects regression models will be applied to test the effect of the intervention., Ethics: Ethics approval has been gained from Curtin University and the participating sites., Dissemination: Results will be reported in international peer-reviewed journals., Trial Registration Number: Australian and New Zealand Clinical Trials Registration (ACTRN)12612001147875., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)