Fertility & Temporality in Pediatric Oncology

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05048771
Study type	Observational
Source	Central Hospital, Nancy, France
Contact
Status	Not yet recruiting
Phase
Start date	September 2021
Completion date	March 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fertility and Temporality in Pediatric Oncology — FERTITOP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms