Skip to main content

Advertisement

Table 1 Characteristics of included studies

From: Effectiveness of decision aids for female BRCA1 and BRCA2 mutation carriers: a systematic review

RCT - Parallel group Author Year of publication Country Time of recruitment Inclusion criteria No. of subjects randomized Control: Comparator Control: No. of subjects Intervention Intervention: No. of subjects
Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations [22] Armstrong 2005 USA 2000–2003 BRCA1- and BRCA2-positive women, with or without BC (no OC, no BC with metastases, no RR-BM + RR-BO) 32 Educational booklet 13 Educational booklet + binder with comprehension exercise, individualized survival curves and individualized BC incidence curves 14
Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction [23] Schwartz 2009 USA 2001–2005 BRCA1- and BRCA2-positive women, with or without BC/OC (no BC with metastases, no OC with metastases, no RR-BM) 214 Usual care 114 Usual care + interactive CD-ROM with information about BC and risk management options, tailored BC and OC risk graphs and an interactive decision task 100
Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial [24] Hooker 2011 USA 2001–2005 BRCA1- and BRCA2-positive women, with or without BC/OC (no BC with metastases, no OC with metastases, no RR-BM) 214 Usual care 114 Usual care + interactive CD-ROM with information about BC and risk management options, tailored breast and ovarian cancer risk graphs and an interactive decision task 100
Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial [25] Metcalfe 2017 Canada 2008–2011 BRCA1- and BRCA2-positive women, without cancer (no RR-M, no RR-O, no tamoxifen) 150 Usual care 74 Usual care + booklet with information about BC risks, BC preventive options, guidelines, studies and a possibility to compare the options 76
RCT - Cross-over trial Author Year of publication Country Time of recruitement Inclusion criteria No. of subjects randomized Control: Comparator Group 1: No. of subjects Intervention Group 2: No. of subjects
Randomised trial of a decision aid and its timing for women being tested for a BRCA1/2 mutation [26] Van Roosmalen 2004 NL 1999–2001 BRCA1- and BRCA2-positive women, with or without BC/OC (no distant metastases, no RR-BM + RR-BO; no chemotherapy, radiotherapy or BC/OC surgery 1 month before blood sampling) 384 Usual care T2 (before gen. Testing, gets DA): 184 T3 (positive test result): 47 Usual care + Brochure with information about treatment options + 45 min. Video with interviews mutation carriers T2 (before gen. Testing, gets no DA): 184 T3 (positive test result, gets DA): 42
One-Group Pretest-Posttest Design Author Year of publication Country Time of recruitement Inclusion criteria No. of subjects willing to participate Subjects completing the pre-test questionnaire Intervention Subjects completing the post-test questionnaire
Development and testing of a decision aid for breast cancer prevention for women with a BRCA1 or BRCA2 mutation [27] Metcalfe 2007 Canada Not specified BRCA1- and BRCA2-positive women, without BC/OC 21 21 Brochure with information about options and outcomes, risks and benefits, a valuing exercise and suggestions for follow-up discussions with their practitioner 20
  1. RCT randomized controlled trial, NL Netherlands, CD-ROM Compact Disc Read-Only Memory, No. number, DA decision aid, BRCA1 breast cancer gene 1, BRCA2 breast cancer gene 2, OC ovarian cancer, BC breast cancer, RR-BM risk-reducing bilateral mastectomy, RR-M risk-reducing mastectomy, RR-BO risk-reducing bilateral oophorectomy, RR-O risk-reducing oophorectomy, T2 4 weeks after blood sampling, T3 2 weeks after positive test result