Decisional Process in Male Fertility Preservation

April 7, 2015 updated by: Wyns, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Fertility Preservation in the Male Pediatric Population: a Patient and Parent Perspective of Factors Influencing the Decisional Process

The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on

  1. patient and parent feelings about fertility preservation counselling
  2. influence of the emotional state of patients and parents on fertility preservation acceptance
  3. support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.

Three different questionnaires, for children (<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.

Study Type

Observational

Enrollment (Actual)

348

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013 and their parents

Description

Inclusion Criteria:

  • prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
<12 years
children under 12 years diagnosed with cancer questionnaire survey
Other: survey
questionnaire survey sent by regular mail for 3 groups
12-18 years
adolescents diagnosed with cancer questionnaire survey
Other: survey
questionnaire survey sent by regular mail for 3 groups
parents
parents of children and adolescents diagnosed with cancer questionnaire survey
Other: survey
questionnaire survey sent by regular mail for 3 groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors improving the decision-making process for fertility preservation
Time Frame: less than 1 year
factors improving the decision-making process for fertility preservation assessed by three specific questionnaires (parent, adolescent and children)
less than 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient and parent feelings about fertility counseling
Time Frame: less than 1 year
patient and parent feelings about fertility counseling assessed by three specific questionnaires (parent, adolescent and children)
less than 1 year
influence of the emotional state of parents and patients on fertility preservation acceptance
Time Frame: less than 1 year
influence of the emotional state of parents and patients on fertility preservation acceptance assessed by three specific questionnaires (parent, adolescent and children)
less than 1 year
support of medical staff and family
Time Frame: less than 1 year
support of medical staff and family assessed by three specific questionnaires support of medical staff and family (parent, adolescent and children)
less than 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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