Clinical trial NCT05403255: Quality of Life and Psychosocial Dimension in Children With Hypopituitarism
Official title: Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital or Acquired Hypopituitarism
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life measurement
timeFrame: 1 day
Secondary outcomes:
measure: Psychosocial parameters
timeFrame: 1 day
measure: Socioeconomic status
timeFrame: 1 day
measure: Fatigue
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux Marseille
state: Bouches-du-Rhône
Study officials:
affiliation: ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
name: François CREMIEUX
role: STUDY_DIRECTOR
affiliation: ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
name: Sarah CASTETS, PH
role: PRINCIPAL_INVESTIGATOR
References: