Quality of Life and Psychosocial Dimension in Children With Hypopituitarism (QALHYPO)

Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital or Acquired Hypopituitarism
• Intervention / Treatment: Other: evaluation of the quality of life with questionnaires

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Sarah CASTETS, PH; Phone Number: 04 91 38 67 30; Email: sarah.castets@ap-hm.fr

Study Locations

• France
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13354
      • Assistance Publique Hôpitaux Marseille
      • Contact: Amandine ROLLAND; Email: amandine.rolland@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The research involves the inclusion of special populations. Indeed, the research plans to include 120 patients aged 10 to 17 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Multiple or isolated pituitary hormone deficiency group; Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months.

Other: evaluation of the quality of life with questionnaires; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measurement	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychosocial parameters	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.	1 day
Socioeconomic status	ENVU questionaire ( Social and health vulnerability identification questionnaire in pediatrics )	1 day
Fatigue	PedsQL multidimensional fatigue scale	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Sarah CASTETS, PH, Assistance Publique Hôpitaux Marseille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (ACTUAL): June 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases; Hypopituitarism
• Other Study ID Numbers: 2022-A00504-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No