Efficacy of two models of delivering information about treatment-focused genetic testing among young women newly diagnosed with breast cancer

Transcription

1 Efficacy of two models of delivering information about treatment-focused genetic testing among young women newly diagnosed with breast cancer Meiser B, 1,2 Rahman B, 1,2 Watts KJ, 1,2 Kirk J, 3 Tucker KJ, 1,2 Saunders C, 4 Gleeson M, 5 Barlow-Stewart K, 6 Mitchell G, 7 1) Department of Medical Oncology, Prince of Wales Hospital, NSW, Australia; 2) Prince of Wales Clinical School, University of New South Wales, NSW, Australia; 3) Westmead Institute for Cancer Research, University of Sydney at Westmead Millennium Institute, NSW, Australia. 4) Department of Surgery, University of Western Australia, WA, Australia; 5) Hunter Genetics, NSW, Australia; 6) Sydney Medical School, University of Sydney, NSW, Australia; WA, Australia; 7) Peter MacCallum Cancer Centre, Vic, Australia;

2 Treatment-focused genetic testing TFGT Growing evidence that knowledge of BRCA1 & BRCA2 mutation status may influence specific treatment recommendations BRCA mutation status increasingly being used to inform surgical decisions Knowledge of BRCA1/2 mutation before definitive surgery significantly increases number of women opting for bilateral mastectomy 1 BRCA mutation status may also influence selection of chemotherapeutic agents and targeted therapies in future Most women with breast cancer and relevant family history are referred for genetic counselling/testing after completion of cancer treatment More women may be offered genetic counselling and testing for BRCA mutations shortly after breast cancer diagnosis 1. Schwartz MD, Lerman C, Brogan B et al. (2005). Utilization of BRCA1/BRCA2 mutation testing in newly diagnosed breast cancer patients. Cancer Epidemiology, Biomarkers & Prevention, 14:

3 Treatment-focused genetic testing TFGT TFGT is rapid genetic testing offered around the time of diagnosis to high-risk patients to guide surgical/treatment decisions TFGT will likely increase burden on familial cancer clinics to provide information and counselling Need to test alternative streamlined models of delivering information about genetic testing around diagnosis

4 TFGT educational materials To test the efficacy of the educational materials randomised controlled trial (RCT) designed

5 Primary aim, outcome & hypothesis Primary aim To test the impact and efficacy of educational materials compared to face-to-face genetic counselling on decisionrelated, psychosocial and surgical (patient) outcomes Primary outcome Decisional conflict in relation to genetic testing choices Primary hypothesis Decisional conflict will not be inferior in the intervention group compared to the control group non-inferiority trial

6 Secondary aims & outcomes Secondary aims Assess the impact of TFGT on other patient outcomes e.g. depression, distress, cancer-related distress Measure the impact of TFGT on uptake of bilateral mastectomy and risk reducing salpingo-oophorectomy (RRSO) Compare cost effectiveness of the two models of information delivery Evaluate health professionals experience of the TFGT process

7 Eligibility criteria Patient is eligible if she has had a previous primary breast cancer

8 What does the study involve? Eligible women are invited into the study by their breast surgeon around the time of diagnosis BEFORE definitive breast cancer treatment (before mastectomy or radiotherapy) Participants are randomly allocated to receive information about TFGT in one of two ways, either in: 1) a written pamphlet (Intervention); OR 2) a standard pre-test consultation at a familial cancer service (Control) Participants complete 4 study questionnaires over 12 months All women are offered TFGT; results take approx 2 weeks All women who have TFGT receive results at a familial cancer service

9 Study process as

10 Results Final sample size 128 women enrolled in the study All 128 participants opted for TFGT Results are reported for change in: Decisional conflict (primary outcome) Depression Anxiety Knowledge Cancer-specific distress Uptake of bilateral mastectomy Uptake of risk-reducing salpingo-oophorectomy

11 Table 1. Participant characteristics (N=128)

12 Table 2. Results for outcome variables as a function of the intervention Variable Control n=64 Intervention n=64 Test statistic, p- value and 95% CI M (SD) M (SD) p 95% CI Decisional conflict 11.8 (16.4) 12.3 (15.4) to 7.5 General distress 15.6 (5.1) 16.5 (5.0) to 2.1 Knowledge 9.0 (1.3) 8.8 (1.4) to 0.3 Cancer-related distress 25.5 (15.7) 28.1 (13.6) to 4.8 No significant differences in the amount of change between groups kconfab 2012

13 Figure 1. Pre and post mean scores for decisional conflict (DC), general distress (GD), cancer-related distress (CDS) and knowledge as a function of group. DCS = Decisional Conflict Scale; HADS = Hospital Anxiety and Depression Scale; IES = Impact of Event Scale.

14 Uptake of risk-reducing surgery Uptake of bilateral mastectomy (BM) Assessed 12-month post-testing 38% had BM, 36% intervention and 40% in control group (p=.73) Uptake significantly higher than comparison group (8%) Comparison group: 703 women aged <50 years with Stage 1-3 breast cancer within 1 year of diagnosis at Royal Perth Hospital Uptake of risk-reducing salpingo-oophorectomy (RRSO) Assessed 12-month post-testing 13% had RRSO, 9% in intervention and 17% in control group (p=.17)

15 Results Primary outcome measure decisional conflict decreased after receiving information about TFGT for both control and intervention groups Secondary outcome measures general distress and cancer-related distress also decreased for both control and intervention groups Secondary outcome measure knowledge increased for both control and intervention groups The mean amount of change did not differ between control and intervention groups

16 Conclusions Results show decisional conflict about genetic testing is not inferior for intervention group compared to control group, as hypothesised Written educational materials may be a safe and effective way of informing women newly diagnosed with breast cancer about TFGT Further analyses will also provide results on impact of TFGT on surgical decisions, cost-effectiveness and experiences of health professionals involved Genetic testing provided me with information to make a more informed decision with regards to my current, ongoing and future treatment (TFGT participant)

17 Acknowledgements Research participants Recruitment sites Prince of Wales Hospital Dr Kathy Tucker, Dr Lesley Andrews, Rachel Williams, Jessica Duffy, Michelle Peate Westmead Hospital Dr Judy Kirk, Dr Hilda High, Michelle Bowman, Leonie Noon St George Hospital Dr Kathy Tucker, Dr Patti Bastick, Risha Zia Royal North Shore Hospital Dr Michael Field, Dr Hilda High, Rebecca Dickson Peter MacCallum Cancer Centre Dr Gillian Mitchell, Linda Cicciarelli Monash Medical Centre Dr Marion Harris, Courtney Smyth Cabrini Institute Dr Yoland Antill, Dr Lara Lipton, Dr Lynne McKay Royal Brisbane and Women s Hospital Dr Rachel Susman, Annette Hattam Nambour General Hospital Dr Sandy Grieve, Karen Crowe Funding: Cancer Australia, Cancer Council Australia & National Breast Cancer Foundation Research team Dr Patrick Kelly School of Public Health, University of Sydney, NSW, Australia Dr Michelle Peate - Prince of Wales Clinical School, UNSW, Australia Professor Elizabeth Geelhoed, University of Western Australia, Perth