Aim of the hereby proposed study 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. Primary outcome is decisional coflict.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
decisional conflict
Secondary outcome
preparation for decision making, informed decision making, value congruence,
knowledge, satisfaction with the decision made, and decisional regret,
reproductive concerns, quality of life
Background 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 (in)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. To our knowledge, this
is the first Dutch initiative of developing a DA for FP. In Australia people
have developed a DA-booklet. Pilot testing of this booklet as decision aid has
provided some initial evidence about the efficacy of the DA in facilitating
informed choices about fertility-treatments. However our DA will be the first
webbased decision aid for FP worldwide.
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.
Study objective
Aim of the hereby proposed study 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. Primary outcome is decisional
coflict.
Study design
The effectiveness of the DA for FP will be evaluated in a prospective,
randomized controlled multi center trial with two follow-up moments within 6
months, and one additional follow-up moment 1-2 years later.
Patients who visit the participating centers will be randomly assigned to one
of the two conditions (control vs intervention). Randomization will be done by
making use of random allocation software. Randomization will take place after
respondents have completed the baseline questionnaire. All respondents receive
a respondent number existing of a letter followed by a number. Each center has
it own letter. This letter will be randomly assigned to the participating
centers. The number indicates the order of the patients; the first eligible
patient receives a 01, the second a 02, the tenth a 10 etc.
Study burden and risks
Participating in this study will not cause any (physical) harm for the
participants.
Participants will be asked to participate in an emotional and difficult period,
after receiving the diagnosis breast cancer. This may be of some discomfort for
the participants. However, it is thought that the participants will have
benefit of the intervention and no harm from the control condition because this
is usual care.
Participants will be asked to fill out questionnaires three times, this may
cause some discomfort because of the time investments they have to make.
Participants will not receive a financial compensation for participating.
VRSP, postbus 9600
2300 RC Leiden
NL
VRSP, postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Women
Diagnosis: breast cancer, ductal
18-40 years old
will soon start treatment for breast cancer
eligible for fertility preservation (probability of POF > 50%, 5-years survival rate >50%, probability of metastasis to the ovaries <0.2%, ductal carcinoma, no previous treatment with chemotherapy, signed informed consent)
Willing to contribute
Internet access at home
In possession of an email address
Exclusion criteria
no access to the internet
recurrent or metastatic tumor
have other cancers than breast cancer
not eligible for fertility preservation
do not have sufficient knowledge of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32155.058.11 |