Clinical trial NCT05048771: Fertility and Temporality in Pediatric Oncology
Official title: Fertility and Temporality in Pediatric Oncology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Issues
Childhood Cancer
Psychology, Social
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2021-09-17
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults treated for childhood cancer in one of the five hospital of the Great Est region or France having a follow-up by a pediatric oncologist.

Brief summary: Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.

Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.

Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.

Patients \& Methods:

300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.

Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.


Eligibility criteria: Inclusion Criteria:

* age between 15 -25
* having been diagnosed with cancer during childhood or adolescence,
* having finished the treatments and being in remission for at least 2 years

Exclusion Criteria:

* Recurrence of cancer at the time of the study
* Lack of cognitive autonomy to be able to agree to participate in the study

Primary outcomes:
measure: Evaluate the impact of infertility on psychological health
timeFrame: december 2023
Secondary outcomes:
measure: Develop a decision aid tool for clinicians designed to increase referral for fertility preservation
timeFrame: december 2023
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital of Besançon
city: Dijon
country: France
facility: University Hospital of Dijon
city: Nancy
country: France
facility: University Hospital of Nancy, France
city: Reims
country: France
facility: University hospital of Reims
city: Strasbourg
country: France
facility: University hospital of Strasbourg
Study officials:
References: