Quality of Life and Psychosocial Dimension in Children With Hypopituitarism

• Conditions: Congenital or Acquired Hypopituitarism
• Interventions: Other: evaluation of the quality of life with questionnaires

• Registration Number: NCT05403255
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Relatively little is known about the quality of life (QOL) of patients with hypopituitarism, particularly children. Quality of life studies have mostly focused on improvements following the initiation of growth hormone treatment in adults with growth hormone deficiency. Overall QOL data on patients with multiple pituitary hormone deficiency or another isolated deficiency are much scarcer. These studies suggest however that pituitary deficiencies affect the QOL and social integration of adults. In children, the psychosocial repercussions of the disease are very poorly understood, particularly in the case of multiple congenital pituitary hormone deficiency.

Detailed Description

Objectives:

* Describe the quality of life and psychosocial repercussions of the disease in children 10-17 years of age with multiple pituitary hormone deficiency (either acquired or congenital), or isolated pituitary hormone deficiency (other than idiopathic isolated growth hormone deficiency).

* Compare the QOL and psychosocial indicators of these patients with those of the general population

* Study the effects of various factors (medical, social, psychological) on patient outcomes and experiences of the disease.

Methods

* Prospective analytical pilot study involving the four hospitals in the Referral Centre for Rare Pituitary Diseases (Centre de Référence des Maladies Rares de l'Hypophyse, HYPO)

* Questionnaire data will be collected among patients and their parents during follow-up consultations.

* Children's quality of life will be evaluated using the Kidscreen-10 questionnaire (for children and parents) and PedsQL multidimensional fatigue scale. Psychosocial indicators (standard of living, schooling, recreation activities, social and family relationships, perceived health status and physical appearance) will be gathered using a questionnaire based on the HBSC (Health Behaviour in School-Aged Children) questionnaire (INPES 2010), and compared with data from the general population of elementary-, middle-and high-school children in France.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03
• Study Start: 2022-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age 10-17 years
• Multiple or isolated pituitary hormone deficiency
• Deficiency diagnosed for a least 6 months

Exclusion Criteria

• Isolated growth hormone deficiency with normal MRI findings and/or no previous irradiation of the hypothalamo-pituitary region and/or no known genetic cause.
• Secondary pituitary deficiency due to a secreting adenoma
• Inability to complete the questionnaire (intellectual disability, low French language proficiency)
• No health coverage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple or isolated pituitary hormone deficiency group	evaluation of the quality of life with questionnaires	Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months.

Primary Outcome Measures

Name	Time	Method
Quality of life measurement	1 day	The KIDSCREEN-10 score consists of 10 items and provides a Rasch-scaled single score of HRQoL. Both self-report and proxy versions will be used.

Secondary Outcome Measures

Name	Time	Method
Fatigue	1 day	PedsQL multidimensional fatigue scale
Psychosocial parameters	1 day	HBSC questionnaires (Aged Behaviour in School-agedd Children, INPES 2014). This international standard questionnaire enables the collection of common data across participating countries and thus enables the quantification of patterns of key health behaviours, health indicators and contextual variables.
Socioeconomic status	1 day	ENVU questionaire ( Social and health vulnerability identification questionnaire in pediatrics )

Trial Locations

Locations (1)

Assistance Publique Hopitaux Marseille; 🇫🇷 Marseille, Bouches-du-Rhône, France