Primary Objectives: Determine oncologic outcomes after fertility-sparing treatment in AYAs with cervical, ovarian or endometrial cancer (Q1). Determine fertility and obstetric outcomes after fertility-sparing treatment in AYAs with cervical, ovarian…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Pregnancy, labour, delivery and postpartum conditions
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Q1: 2-year and 5-year recurrence free survival
Q2:Percentage of women trying to conceive, within this group: pregnancy rate
(number of first pregnancies after treatment divided by the number of women who
tried to conceive) and number of pregnant women divided by the number of women
who tried to conceive after treatment.
Live birth rate
Q3:Initiation of pursuing pregnancy
Psychological outcome: reproductive concerns, anxiety and depression, cancer
worries and decisional regret.
Secondary outcome
Q1: 2- and 5-year survival and overall survival Q2:Type of conception
(artificial or spontaneous) Miscarriages, gestational age at delivery (preterm
<28 weeks, preterm 28-32 weeks, preterm 32-37 weeks, term), mode of delivery
(induction, caesarean section, spontaneous labor)
Background summary
Every year, approximately 350 women between 18-39 years old are diagnosed with
cervical, ovarian or endometrial cancer in the Netherlands. This age group is
called AYAs (adolescents and young adults). Due to early detection and
advancements in cancer treatment, survival of patients has improved. As a
result, the focus of oncologic treatment has expanded from survival only,
towards quality of life (QoL) after surviving cancer. Preservation of fertility
is an important factor to achieve good QoL in AYAs. However, fertility can be
impaired by surgery or gonadotoxic effects of cancer treatment. Therefore,
fertility-sparing treatment could be offered to patients with early stage
disease and the wish to preserve fertility. However, data on oncological safety
and obstetrical outcomes after these procedures are scarce and based on small
retrospective series. Furthermore, the majority of these women eventually
decide not to pursue pregnancy after fertility-sparing treatment. The factors
that influence these decisions regarding fertility-sparing treatment and
pursuit of a subsequent pregnancy, and the psychological consequences of these
choices are unknown. With this study, we will create a large national
retrospective database on oncologic, obstetric and psychologic outcomes after
fertility-sparing treatment in gynaecological cancers. This will provide
sufficient data to help future AYAs to make a well-informed decision on their
preferred cancer treatment in the light of oncological and psychological
consequences of the chosen treatment modality.
Study objective
Primary Objectives:
Determine oncologic outcomes after fertility-sparing treatment in AYAs with
cervical, ovarian or endometrial cancer (Q1).
Determine fertility and obstetric outcomes after fertility-sparing treatment in
AYAs with cervical, ovarian or endometrial cancer (Q2).
Determine factors that influence initiation of pursuing pregnancy, and
psychological outcomes in AYAs with cervical, ovarian or endometrial cancer
(Q3).
Study design
National, multicentre, retrospective and cross-sectional study. Collection of
data using electronic health records (EHRs), self-report questionnaires,
semi-structured interviews.
Study burden and risks
Participation is not associated with any risks. A psychological burden could be
experienced by filling out the questionnaires, since the questions are related
to fertility, (possible unfulfilled) pregnancy wish, concerns, and regret.
However, participation is voluntary, and patients can withdraw from
participation at any time. The duration of all (online) questionnaires is 30-45
minutes (Q2/Q3). The interview study will take maximum of 45 minutes. 48 women
and 12 partners will be invited. These interviews take place on location or via
teams. The interviews with the partner will be held seperately.
There are no direct benefits for participants in this study. However, with
their participation they contribute to the collection of important data to
improve the care of future AYAs with a wish to preserve fertility after cancer
treatment.
albinusdreef 2
Leiden 2333 ZA
NL
albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Women with cervical, ovarian or endometrial cancer
- Age between 18-39 at time of diagnosis
- Fertility-sparing treatment between 2000 and 2020
Exclusion criteria
For the questionnaire and interviewstudy:
- Living abroad and untraceable at time of data collection
- Deceased at time of data collection
- Insufficient understanding of the Dutch language
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL80232.058.22 |