QALHYPO: Quality of Life and Psychosocial Dimension in Children With Hypopituitarism

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05403255

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital or Acquired Hypopituitarism	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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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 )
Fatigue [1 day]
PedsQL multidimensional fatigue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux Marseille	Marseille	Bouches-du-Rhône	France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: François CREMIEUX, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Principal Investigator: Sarah CASTETS, PH, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT05403255

Other Study ID Numbers:

2022-A00504-39

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypopituitarism

Study Results

No Results Posted as of Jun 3, 2022