Fertility and Temporality in Pediatric Oncology

• Conditions: Childhood Cancer; Fertility Issues; Psychology, Social
• Interventions: Other: Questionnaire

• Registration Number: NCT05048771
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-08
• Last Update Submitted: 2021-09-08
• Study First Posted: 2021-09-17
• Last Update Posted: 2021-09-17
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FERTITOP	Questionnaire	300 patients (15-25 years) from 5 different hospitals (University Hospitals of Nancy, Strasbourg, Reims, Besançon, Dijon (France)) who have finished all cancer treatments for at least 2 years.

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of infertility on psychological health	december 2023	Patients will report the outcomes of the infertility risks on the questionnaire provided in this study.; Positive and negative impacts will be questioned.

Secondary Outcome Measures

Name	Time	Method
Develop a decision aid tool for clinicians designed to increase referral for fertility preservation	december 2023	Using the factors that facilitate or hinder referral to fertility preservation to create a tool for clinicians designed to increase the referral for fertility preservation of children and adolescents with cancer

Trial Locations

Locations (5)

University Hospital of Besançon; 🇫🇷 Besançon, France

University Hospital of Nancy, France; 🇫🇷 Nancy, France

University hospital of Reims; 🇫🇷 Reims, France

University Hospital of Dijon; 🇫🇷 Dijon, France

University hospital of Strasbourg; 🇫🇷 Strasbourg, France