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

Overview

Journal Cancer Med

Specialty Oncology

Date 2023 Aug 21

PMID 37602539

Authors

Kelly A Metcalfe

Tuya Pal

Steven A Narod

Susan Armel

Salma Shickh

Kathleen Buckley

Scott T Walters

Sarah Brennenstuhl

Anita Y Kinney

Affiliations

Soon will be listed here.

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 <0.001) and a higher mean knowledge score at one-year compared to usual care (p <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.

Citing Articles

Uptake of Risk-Reducing Salpingo-Oophorectomy and Gynaecologic Surveillance Among Germline BRCA Pathogenic Variants Carriers.

Inzoli A, Negri S, DellOro C, Costa C, Marchetta L, Boccadutri M Cancer Med. 2024; 13(23):e70321.

PMID: 39624976 PMC: 11612664. DOI: 10.1002/cam4.70321.

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.

Metcalfe K, Pal T, Narod S, Armel S, Shickh S, Buckley K Cancer Med. 2023; 12(17):18246-18257.

PMID: 37602539 PMC: 10524042. DOI: 10.1002/cam4.6417.

References

Metcalfe K, Pal T, Narod S, Armel S, Shickh S, Buckley K . 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; 12(17):18246-18257. PMC: 10524042. DOI: 10.1002/cam4.6417. View

Metcalfe K, Eisen A, Senter L, Armel S, Bordeleau L, Meschino W . International trends in the uptake of cancer risk reduction strategies in women with a BRCA1 or BRCA2 mutation. Br J Cancer. 2019; 121(1):15-21. PMC: 6738089. DOI: 10.1038/s41416-019-0446-1. View

Torre L, Trabert B, DeSantis C, Miller K, Samimi G, Runowicz C . Ovarian cancer statistics, 2018. CA Cancer J Clin. 2018; 68(4):284-296. PMC: 6621554. DOI: 10.3322/caac.21456. View

Metcalfe K, Dennis C, Poll A, Armel S, Demsky R, Carlsson L . Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial. Genet Med. 2016; 19(3):330-336. DOI: 10.1038/gim.2016.108. View

Pengchit W, Walters S, Simmons R, Kohlmann W, Burt R, Schwartz M . Motivation-based intervention to promote colonoscopy screening: an integration of a fear management model and motivational interviewing. J Health Psychol. 2011; 16(8):1187-97. PMC: 3162074. DOI: 10.1177/1359105311402408. View

Gronwald J, Lubinski J, Huzarski T, Cybulski C, Menkiszak J, Siolek M . A comparison of ovarian cancer mortality in women with BRCA1 mutations undergoing annual ultrasound screening or preventive oophorectomy. Gynecol Oncol. 2019; 155(2):270-274. DOI: 10.1016/j.ygyno.2019.08.034. View

Metcalfe K, Liede A, Hoodfar E, Scott A, Foulkes W, Narod S . An evaluation of needs of female BRCA1 and BRCA2 carriers undergoing genetic counselling. J Med Genet. 2000; 37(11):866-74. PMC: 1734476. DOI: 10.1136/jmg.37.11.866. View

Horowitz M, WILNER N, Alvarez W . Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979; 41(3):209-18. DOI: 10.1097/00006842-197905000-00004. View

Elit L, Esplen M, Butler K, Narod S . Quality of life and psychosexual adjustment after prophylactic oophorectomy for a family history of ovarian cancer. Fam Cancer. 2003; 1(3-4):149-56. DOI: 10.1023/a:1021119405814. View

10.

Fry A, Busby-Earle C, Rush R, Cull A . Prophylactic oophorectomy versus screening: psychosocial outcomes in women at increased risk of ovarian cancer. Psychooncology. 2001; 10(3):231-41. DOI: 10.1002/pon.512. View

11.

Thompson-Leduc P, Turcotte S, Labrecque M, Legare F . Prevalence of clinically significant decisional conflict: an analysis of five studies on decision-making in primary care. BMJ Open. 2016; 6(6):e011490. PMC: 4932317. DOI: 10.1136/bmjopen-2016-011490. View

12.

OConnor A . Validation of a decisional conflict scale. Med Decis Making. 1995; 15(1):25-30. DOI: 10.1177/0272989X9501500105. View

13.

Xi W, Pennell M, Andridge R, Paskett E . Comparison of intent-to-treat analysis strategies for pre-post studies with loss to follow-up. Contemp Clin Trials Commun. 2018; 11:20-29. PMC: 6022256. DOI: 10.1016/j.conctc.2018.05.008. View

14.

Finch A, Lubinski J, Moller P, Singer C, Karlan B, Senter L . Impact of oophorectomy on cancer incidence and mortality in women with a BRCA1 or BRCA2 mutation. J Clin Oncol. 2014; 32(15):1547-53. PMC: 4026578. DOI: 10.1200/JCO.2013.53.2820. View

15.

Kuchenbaecker K, Hopper J, Barnes D, Phillips K, Mooij T, Roos-Blom M . Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017; 317(23):2402-2416. DOI: 10.1001/jama.2017.7112. View

16.

Witte K, Cameron K, McKeon J, Berkowitz J . Predicting risk behaviors: development and validation of a diagnostic scale. J Health Commun. 1996; 1(4):317-41. DOI: 10.1080/108107396127988. View

17.

Robson M, Hensley M, Barakat R, Brown C, Chi D, Poynor E . Quality of life in women at risk for ovarian cancer who have undergone risk-reducing oophorectomy. Gynecol Oncol. 2003; 89(2):281-7. DOI: 10.1016/s0090-8258(03)00072-6. View

18.

Tiller K, Meiser B, Butow P, Clifton M, Thewes B, Friedlander M . Psychological impact of prophylactic oophorectomy in women at increased risk of developing ovarian cancer: a prospective study. Gynecol Oncol. 2002; 86(2):212-9. DOI: 10.1006/gyno.2002.6737. View

19.

Finch A, Narod S . Quality of life and health status after prophylactic salpingo-oophorectomy in women who carry a BRCA mutation: A review. Maturitas. 2011; 70(3):261-5. DOI: 10.1016/j.maturitas.2011.08.001. View

20.

Kinney A, Boonyasiriwat W, Walters S, Pappas L, Stroup A, Schwartz M . Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. J Clin Oncol. 2014; 32(7):654-62. PMC: 3927734. DOI: 10.1200/JCO.2013.51.6765. View