Fertility and Temporality in Pediatric Oncology

NCT05048771 | Unknown DMC

• 1 other identifier: 2019PI269
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Fertility Issues; Childhood Cancer; Psychology, Social

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of infertility on psychological health

  Patients will report the outcomes of the infertility risks on the questionnaire provided in this study. Positive and negative impacts will be questioned.

  december 2023

Secondary Outcomes (1)

• Develop a decision aid tool for clinicians designed to increase referral for fertility preservation

  december 2023

Study Arms (1)

FERTITOP

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.

Other: Questionnaire

Interventions

Questionnaire OTHER

Patients will be surveyed through self-administered questionnaires and semidirected interviews with a psychologist

Also known as: Interview

FERTITOP

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• National Cancer Institute, France: collaborator

Study Sites (5)

University Hospital of Besançon

Besançon, France

Location

University Hospital of Dijon

Dijon, France

Location

University Hospital of Nancy, France

Nancy, 54000, France

Location

University hospital of Reims

Reims, France

Location

University hospital of Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Infertility; Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 17, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

FR (5)