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Table 3 Methodological descriptions of the studies (N = 9)

From: Reasons for and against participation in studies of medicinal therapies for women with breast cancer: a debate

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