|- candidate number||10252|
|- NTR Number||NTR3054|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-aug-2011|
|- Secondary IDs||P11.027 METC LUMC|
|- Public Title||Evaluation of information provision about fertility sparing treatments for women with breast cancer.|
|- Scientific Title||Effect evaluation of a Decision Aid for Fertility Preservation in Women with Breast cancer: A Randomized Controlled Trial in the Netherlands.|
|- hypothesis||We expect that the Decision Aid will support patients in deciding about fertiliy preservation prior to their cancer treatment by decreasing decisional conflict.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Risc, Premenopausal women, Premature ovarian failure (POF)|
|- Inclusion criteria||1. Women;|
2. 18-40 years old;
3. Diagnosed with breast cancer;
4. Will soon start their breast cancer treatment;
5. Eligible for FP;
6. Have an email address.
|- Exclusion criteria||No sufficient knowledge of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-jun-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||400|
|- Interventions||Information provision trough a Webbased decision aid (intervention) about fertility preservation compared to general patient brochures (control) about fertility preservation. The effect of the intervention will be measured by making use of self report questionnaires.
The intervention is a webbased decision aid (website) with information about the consequences of breast cancer treatment on fertility, fertility preservation options, options to fulfill a desire for children when fertility preservation is not possible, background information on normal fertility. Furthermore, the website consists of an explicit value clarification exercise by which patients can deliberate values that are important for them in the decision whether or not to undergo fertility preservation. Subsequently, patients' answers are sorted from most important (as defined by the patient) to least important. No advice is given.
Patients can decide for themselves how much time they spend on the website and what proportion they read, or use.
|- Primary outcome||(Measured with a questionnaire).|
Decisional conflict as measured with the decisional conflict scale (DCS, O'connor, 1995).
|- Secondary outcome||(All measured with questionnaires).|
Satisfaction with decision making (subscale dcs), preparation for decision making (Bennet et al 2010), decisional regret (Brehaut et al 2003), reproductive concerns (Wenzel et al 2005), risk perception, knowledge, attitude, preference/uptake, health literacy (Chew et al 2004), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EORTC-QLQ-C30).
|- Timepoints||T0: Baseline (after registration);|
T1: 6 weeks;
T2: 6 months;
T3: 1-2 years.
|- Trial web site||www.borstkankerenkinderwens.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Mirjam M. Garvelink|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Mirjam M. Garvelink|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Pink Ribbon, DSW Health Insurance|
|- Brief summary||Because survival chances for women with breast cancer are high, quality of life (QOL) after treatment is becoming more important. Infertility, or concerns about fertility, due to the cancer treatment have a negative influence on the QOL. Therefore, interest in possibilities for fertility preservation (FP) has risen. At this moment, options to preserve fertility prior to oncologic treatment in the Netherlands are cryopreservation of in vitro fertilized embryos, oocytes and ovarian tissue, or suppression of the ovaries. Despite an increasing number of studies and guidelines demonstrating the need of discussion of FP issues with young cancer patients, information provision about treatment-induced infertility and FP techniques is not sufficient. |
Sufficient and clear information is necessary to enable informed decision making. To support informed decision making and improve information provision, we have developed a web-based Decision Aid (DA) on FP. With the availability of this DA, every patient who is eligible for counseling on FP can obtain optimal counseling at any location in the Netherlands. Aim of this RCT is to evaluate the DA for FP on its effectiveness compared to treatment as usual (TAU) regarding outcomes of decision making and decision making processes.
|- Main changes (audit trail)||09-Feb-2012: Amendment of KEEP-study - NM|
Since the start of the KEEP-study (June 2011), there were problems with inclusion of enough participants. This because of the short time frame between diagnosis and counseling about fertility preservation (often some days), in which patients (or their clinician) had to contact the researcher who would send the first questionnaire, randomize and give access to either the website (intervention) or brochures (control), patients had to fill in the first questionnaire and read the website or brochures. This, in combination with the many studies that are offered to breast cancer patients, often seemed a reason for clinicians not to invite patients or for patients to decline participation.
Therefore, the design of the KEEP has been changed to an implementation study with one study-arm (the intervention: a website about fertility preservation treatments). By excluding the 50% chance to be randomized in the control condition, and thus offering all women the intervention, we aim to include as many eligible women as possible. Furthermore, patients can immediately access the website with the username they receive from their oncologist, which saves much time.
As a control group, a historical control group consisting of women who have been treated for breast cancer in the months before start of the KEEP-study (depending on the date each medical center started with the KEEP study between June 2011 and December 2012) is send one questionnaire.
Most important change: No randomization, only one study arm (intervention).
No changes were made in measurements (3 questionnaires) or inclusion criteria.
|- RECORD||17-aug-2011 - 9-feb-2013|