Determine AYA*s experiences and needs related to FP(C) and follow-up care after FP(C) (Q1); determine the number of AYAs pursuing to conceive and their fertility and obstetric outcome(s) after FP(C) after gonadotoxic treatment (Q2); determine…
ID
Source
Brief title
Condition
- Other condition
- Reproductive tract disorders NEC
Synonym
Health condition
psychische symptomen, waaronder angst en depressieve symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients experiences and needs related to FPC and follow-up care after FP(C),
assessed with self-report questionnaires, and semi-structured interviews (Q1);
The fertility and obstetric out-come(s), percentage of AYAs pursuing to
conceive (both with and without reproductive assis-tance) post gonadotoxic
treatment, and within this group the pregnancy rate and live birth rate,
assessed with self-report questionnaires (Q2); Initiating of pursuing pregnancy
(yes/no) and pursuing pregnancy (months of trying to conceive); psychological
factors (: anxiety- and depression levels, reproductive concern, cancer worries
and decisional regret), relational fac-tors (: relationship status and
duration), biographical (:age, BMI, intoxications), somatic (: medical history)
are assessed with validated self-report questionnaires (Q3). Additional, we
will further explore these psychological factors related to the (initiating of)
pursuing pregnancy in semi-structured interviews (Q3).
Secondary outcome
Psychological distress (anxiety and depression), desire for children; and
possible mediators: reproductive concerns, gender identity concerns, and
self-esteem, are assessed with validated self-report questionnaires. The
moderator, parenthood status is defined by whether the AYA is a parent (yes/no)
(Q4)
Background summary
With better survival rates for female Adolescents and Young Adults (AYA)
patients diagnosed with cancer, more attention has been paid to future risks
such as fertility decline due to gonadotoxic treatment. Fertility preservation
counselling (FPC) and eventually fertility preservation (FP) is offered to
these AYA patients that face a gonadotoxic treatment. Little is known about
AYA*s needs related to follow-up care after FP(C), including the psychological
effects of facing potential fertility decline. Furthermore, usage rate of
cryopreserved material is relatively low and the majority of these women
eventually decide not to pursue pregnancy after FP. The factors that influence
these decisions regarding pursuit of a subsequent pregnancy, and the
psychological consequences of these choices are unknown.
Study objective
Determine AYA*s experiences and needs related to FP(C) and follow-up care after
FP(C) (Q1); determine the number of AYAs pursuing to conceive and their
fertility and obstetric outcome(s) after FP(C) after gonadotoxic treatment
(Q2); determine factors in AYAs that may be associated with (initiation of)
pursuing pregnancy (Q3) and secondary, exploring factors that are associated
with psychological distress and desire for a children among AYAs (Q4).
In this overarching project we aim to develop a standard set of Patient
Reported Outcome Measures (PROMs), regarding to the counseling-, treatment- and
follow up procedure of AYA patients that face a gonadotoxic treatment. With
these PROMs we aim to develop validated questionnaires to implement in a Value
Based Health Care (VBHC) pathway. These, and PROMs at counseling and treatment
will be used to develop a VBHC pathway; we believe that such a VBHC pathway
will help in optimizing the experiences and needs of AYA patients in all phases
encompassing FP.
Study design
Single centre retrospective and cross-sectional study. Collection of data using
electronic health records (EHRs) and self-report questionnaires in phase 1, and
semi-structured inter-views in phase 2.
Study burden and risks
Participation is not associated with any risks. A psychological burden could be
experienced by filling out the questionnaire or participating in the interview,
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 the (online)
questionnaire is 30-45 minutes (Q1/Q2/Q3/Q4), and the duration of the interview
is +- 45 minutes (Q3).
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 future 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, who underwent potentially gonadotoxic treatment (chemotherapy and/or
radio-therapy) because of diagnosis of cancer
- age between 18-39 years at time of FPC
- Visited the fertility clinic of the LUMC for FP(C) between 2012- 2023
Exclusion criteria
- Non-curabel treatment
- Living abroad and untraceable at time of data collection
- Deceased at time of data collection or
- Insufficient understanding of the Dutch language
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86853.058.24 |