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Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Randomized controlled trial of a telephone-based peer-support program for women carrying a BRCA1 or BRCA2 mutation:
Victoria M White1, Mary-Anne Young2, Ashley Farrelly2
1Victoria M. White, Ashley Farrelly, and Michael Jefford, Cancer Council Victoria; Elizabeth Williamson and Ingrid Winship, The University of Melbourne; Ingrid Winship, Royal Melbourne Hospital; Elizabeth Williamson, Monash University, Melbourne; Mary-Anne Young and Michael Jefford, Peter MacCallum Cancer Centre, East Melbourne; Sandra Ieropoli, Early in Life Mental Health Service, Monash Health Mental Health Program, Clayton, Victoria; Bettina Meiser, Prince of Wales Clinical School, The University of New South Wales, Sydney; and Jessica Duffy, Hereditary Cancer Clinic, Prince of Wales Hospital, Randwick, New South Wales, Australia. Vicki.White@cancervic.org.au.
Purpose:
To assess the effectiveness of a telephone-based peer-delivered intervention in reducing distress among women with a BRCA1 or BRCA2 gene mutation. The intervention involved trained peer volunteers contacting women multiple times over a 4-month period to provide informational, emotional, and practical support.
Methods:
Three hundred thirty-seven participants completed the baseline questionnaire, and those reporting interest in talking to other mutation carriers were randomly assigned to either the usual care group (UCG; n = 102) or the intervention group (IG; n = 105). Participants and researchers were not blinded to group allocation. Two follow-up questionnaires were completed, one at the end of the intervention (4 months after random assignment, time 2) and one 2 months later (time 3). Outcomes included breast cancer distress (primary outcome), unmet information needs, cognitive appraisals about mutation testing, and feelings of isolation.
Results:
There was a greater decrease in breast cancer distress scores in the IG than UCG at time 2 (mean difference, -5.96; 95% CI, -9.80 to -2.12; P = .002) and time 3 (mean difference, -3.94; 95% CI, -7.70 to -0.17; P = .04). There was a greater reduction in unmet information needs in the IG than UCG (P < .01), with unmet needs being lower in the IG than UCG at time 2. There was a greater reduction in Cognitive Appraisals About Genetic Testing stress subscale scores in the IG than UCG (P = .02), with significantly lower scores among the IG than UCG at time 2 (P < .01).
Conclusion:
The intervention is effective in reducing distress and unmet information needs for this group of women. Identifying strategies for prolonging intervention effects is warranted.