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

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Congenital or Acquired Hypopituitarism

Treatments

Other: evaluation of the quality of life with questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT05403255

2022-A00504-39

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

No 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