Theory-based behavior change intervention to increase uptake of risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 pathogenic variant: The PREVENT randomized controlled trial

Kelly A Metcalfe; Tuya Pal; Steven A Narod; Susan Armel; Salma Shickh; Kathleen Buckley; Scott T Walters; Sarah Brennenstuhl; Anita Y Kinney

doi:10.1002/cam4.6417

Theory-based behavior change intervention to increase uptake of risk-reducing salpingo-oophorectomy in women with a BRCA1 or BRCA2 pathogenic variant: The PREVENT randomized controlled trial

Cancer Med. 2023 Sep;12(17):18246-18257. doi: 10.1002/cam4.6417. Epub 2023 Aug 21.

Authors

Kelly A Metcalfe^{1

2}, Tuya Pal³, Steven A Narod², Susan Armel⁴, Salma Shickh⁵, Kathleen Buckley⁶, Scott T Walters⁷, Sarah Brennenstuhl¹, Anita Y Kinney^{8

9}

Affiliations

¹ Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.
² Women's College Research Institute, Toronto, Ontario, Canada.
³ Vanderbilt-Ingram Cancer Center at the Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁴ Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
⁵ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
⁶ Grand River Hospital, Kitchener, Ontario, Canada.
⁷ University of North Texas Health Science Center, Fort Worth, Texas, USA.
⁸ Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.
⁹ Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, Piscataway, New Jersey, USA.

Abstract

Objective: To evaluate the effect of a theory-based behavioral intervention delivered by genetic counselors on the uptake of risk-reducing salpingo-oophorectomy (RRSO) at 12 and 24 months by women with a BRCA1 or BRCA2 pathogenic variant (PV) compared to women who received usual care.

Methods: In this two-arm, multi-site randomized controlled trial participants were randomized to receive a theoretically-guided behavioral telephone intervention or usual care. Outcome data were collected at 12 and 24 months. Participants in the usual care arm were offered the intervention after 12 months.

Results: Data on 107 participants were included in the analysis. There was no significant difference in the proportion of women who had a RRSO by 1 year (28.6%- intervention; 22.9%- usual care (p = 0.54)). At 1 year, women who received the intervention had significantly lower mean decisional conflict (p_interaction <0.001) and a higher mean knowledge score at one-year compared to usual care (p_interaction <0.001). At 2 years, 53.9% of participants in the intervention arm had RRSO compared to 32.6% in usual care (p = 0.05).

Conclusions: A theory-based behavioral intervention delivered by genetic counselors to women with a BRCA PV who chose not to have the recommended RRSO was effective at reducing decisional conflict and increasing knowledge in women with a BRCA1 or BRCA2 PV.

Keywords: BRCA1; BRCA2; cancer genetics; cancer prevention; clinical management.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

BRCA1 Protein / genetics
BRCA2 Protein / genetics
Breast Neoplasms*
Female
Genetic Predisposition to Disease
Humans
Mutation
Ovarian Neoplasms* / genetics
Ovarian Neoplasms* / prevention & control
Risk Reduction Behavior
Salpingo-oophorectomy

Substances

BRCA1 Protein
BRCA1 protein, human
BRCA2 protein, human
BRCA2 Protein

Grants and funding

CIHR/Canada