|- candidate number||10147|
|- NTR Number||NTR2982|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jul-2011|
|- Secondary IDs||2009-4535 / PTC11.1432/P11TIS; NKI / KWF|
|- Public Title||Consent Studie.|
|- Scientific Title||The Tissue Issue: Towards a uniform consent procedure for research with excised (cancer) tissue.|
|- hypothesis||1. Patients’ will be significantly more satisfied with the informed consent and opt-out plus consent procedures than with the opt-out consent procedure;|
2. Most patients will prefer the opt-out plus consent procedure, the lowest proportion of patients will prefer the opt-out consent procedure;
3. Significantly more patients will be aware of storage of tissue and research use in the informed consent and opt-out plus procedures than in the opt-out procedures;
4. Consent rates will be highest in opt-out and opt-out plus;
5. Members of the medical staff will be most satisfied with and prefer the opt-out and opt-out plus procedures.
|- Healt Condition(s) or Problem(s) studied||Cancer, Opt-out, Residual tissue, Patient information, Research|
|- Inclusion criteria||Patients between the ages of 18 and 80 years whose tissue has been removed.|
|- Exclusion criteria||Unability to speak and read Dutch. Unability to complete the questionnaires.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-aug-2011|
|- planned closingdate||1-aug-2014|
|- Target number of participants||1800|
|- Interventions||1. Opt-out;|
2. Opt-out plus;
3. Informed consent.
Three consent procedures will be compared. The first, opt-out, is currently the standard condition in most Dutch hospitals. Patients are not actively offered any information about residual tissue use. People may object to the use of their residual tissues. In the second procedure, opt-out plus, patients are actively informed about residual tissue use, after which they may object to this use. The third procedure is an informed consent procedure, in which patients are actively informed, after which they are asked to mark their decision on a form.
|- Primary outcome||1. Patients’ satisfaction with and preference for a consent procedure;|
2. Proportion of patients aware of storage of tissue and research use;
3. Consent rates;
4. Medical staff’s satisfaction with and preference for a consent procedure.
|- Secondary outcome||Additionally, we will obtain information on the proportion of non-consent due to non-response; the characteristics of non-consenters and non-respondents; and the reasons for providing or withholding consent or (non-)response. We will investigate how patients perceived the information they received about residual tissue use and their knowledge about this topic. Patients’ preferences to provide or withhold consent for specific types of research (e.g. genetic, commercial) and feedback regarding unanticipated findings will be investigated as well. Further, we will examine whether consent rates, satisfaction with or preference for a consent procedure differ according to severity of disease, type of clinical procedure (e.g., biopsies or surgical removal of tissue), diagnosis, type of hospital (academic or community) or demographics. Six months after the first questionnaire, we will examine whether patients are still aware of the decision they made and whether they are still satisfied with their choice to provide or withhold consent.|
|- Timepoints||1. Intervention (shortly before or after tissue removal);|
2. 6 weeks after intervention (paper questionnaire);
3. 7 weeks after intervention (telephone interview, 25% of respondents);
4. 6 months after intervention (paper questionnaire).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. S. Rebers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M.K. Schmidt|
|- Sponsor/Initiator ||KWF Kankerbestrijding|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
Human samples obtained during standard clinical care, such as tissue from surgery or blood, are being increasingly collected, banked and used in basic, translational and clinical research. This tissue is referred to as residual tissue, as compared to (extra) tissue specifically collected for scientific research. There is currently no standard procedure in the Netherlands that prescribes whether and how patients should be asked consent for the use of residual tissue. Empirical data about patients’ preferences and wishes regarding information and consent procedures for such use is scarce, and the available research results have not been translated to clinical practice.
This KWF-funded project aims to determine patient preferences for and satisfaction with consent procedures regarding the use of residual tissue for research; to provide insight into the type of information patients need to decide on the use of their material in research; and to determine the feasibility of the timing and content of these procedures in clinical practice. We will compare three consent procedures with respect to several study outcomes: consent rates, and patients’ and medical staff’s satisfaction with and preferences for these procedures.
In this multicentre, randomized controlled trial, 1800 patients will be recruited from four hospitals in the Netherlands (expected response rate 75%). Patients will be randomized to three study arms. In the ‘informed consent’ and ‘opt-out plus’ arms, patients are informed about residual tissue use both verbally and through a specific leaflet. These leaflets contain a consent form and an opt-out form respectively. In the third arm, the control group, no (extra) information about residual tissue use is offered, and patients may opt-out of the use of their residual tissue verbally or written. Patients to be included will be stratified by hospital and condition. Two academic and two regional hospitals will be included. Inclusion of both categories of hospitals and of patients with malignant and non-malignant diseases will increase the generalizability of the study results.
Six weeks after the intervention, patients will receive a questionnaire addressing satisfaction with and preference for the consent procedures. One quarter of the respondents will be interviewed about these topics through a semi-structured telephone interview. Six months after the intervention, respondents will receive a second questionnaire to examine whether those who made a decision about the use of their residual tissue are still aware of that decision and, if they are, whether they are still satisfied with it.
Clinicians and nurses who will carry out the interventions will receive a pre- and post-experimental questionnaire to examine their opinions about and experiences with the consent procedures.
Expected result of this study will be an information procedure that is in accordance with patients’ wishes and research needs and which can be uniformly applied in all Dutch hospitals. This will contribute to the debate about the improvement of regulations (by law or self-regulation) regarding the use of residual tissue for research.
|- Main changes (audit trail)|
|- RECORD||12-jul-2011 - 30-aug-2011|