Reference | Country | Objective/Question | Design | Method | Participants | Data analysis |
---|---|---|---|---|---|---|
Altschuler & Somkin 2005 [19] | USA | Why did women who initially showed interest in participating in the STAR trial make different decisions about whether to participate or not participate? (tamoxifen or raloxifene) | Qualitative chemo-prevention study | Half-structured deep interviews | 51 post-menopausal women with high breast cancer risk(28 participants and 23 non-participants) | Grounded theory |
Ellis et al 2002 [11] | Canada | Evaluation of information brochure, regarding theoretical willingness to participate in a 6-month clinical trial for breast cancer treatment (Tamoxifen alone, chemotherapy alone or combined) | Quantitative before-after-study | Questionnaires closed answers | Before: 83 women with early invasive breast cancer After: 67 women | Descriptive statistics |
Houlihan et al 2010 [12] | USA | Investigation of factors influencing women's decision to participate in breast cancer prevention trial (tamoxifen, raloxifene). | Quantitative case-control study | Questionnaires through mail | Of 242 post-menopausal women, 81 participated | Logistic regression model |
Kim et al 2004 [13] | USA | When financial conflicts of interest were stated on consent forms, which respondents refused to participate in a study using a new medication solely on the basis of these conflicts of interest? | Quantitative study | Internet questionnaires; closed answers | 1006 female breast cancer patients | Descriptive statistics |
Lemieux et al 2008 [14] | Canada | Identifying barriers in the study protocols, with respect to the low recruitment rates in clinical breast cancer trials, 1997-2002. | Quantitative study | Questionnaires; closed answers | 616 women participated in studies of Phase III (or II+ III) and 72 in studies of Phase II (or I+II). | Multivariate analysis |
Loehberg et al 2010 [15] | Germany | Identification of characteristics of women who wanted to receive information about a Phase II chemoprevention study. | Quantitative, multi-centered study | Questionnaires | 202 women of 446 wanted to receive further information about the risk of breast cancer; 3 women decided to participate. | Descriptive statistics |
Mancini et al 2007 [16] | France | Identification of preferences in decision-making processes in relation to participation in another clinical drug trial. | Quantitative, prospective cohort study | Questionnaires | Of 455 women 267 were invited to the study; of these 201 agreed to participate and 66 declined. | Descriptive statistics and multivariate analysis |
Mandelblatt et al 2005 [17] | USA | Effectiveness of a brief consultation and an informational brochure compared with use of brochure only in recruitment for a breast cancer prevention study. (tamoxifen and raloxifene) | Quantitative, simple randomized controlled study | Questionnaires | 232 of 450 women participated in consultation +brochure-group; 218 of 450 in the brochure-only-group | Descriptive statistics and logistical regression model |
Rondanina et al 2008 [18] | Italy | Socio-demographic, health-related and psychological factors influencing decision to participate or not in a five-year hormone replacement therapy. (HRT-Phase III, low-dose tamoxifen) | Quantitative study | Questionnaires through mail | 496 of 1457 women participated in the HET-study | Descriptive statistics and multivariate analysis |