Quality of Life and Psychosocial Dimension in Children With Hypopituitarism

NCT ID: NCT05403255

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-01-01

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.

Conditions

Congenital or Acquired Hypopituitarism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple or isolated pituitary hormone deficiency group

Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months.

evaluation of the quality of life with questionnaires

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Sarah CASTETS, PH

Role: PRINCIPAL_INVESTIGATOR

ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Locations

Assistance Publique Hopitaux Marseille

Marseille, Bouches-du-Rhône, France

Countries

France

Central Contacts

Sarah CASTETS, PH

Role: CONTACT

sarah.castets@ap-hm.fr

04 91 38 67 30

Facility Contacts

Amandine ROLLAND

Role: primary

amandine.rolland@ap-hm.fr

Other Identifiers

2022-A00504-39

Identifier Type: -

Identifier Source: org_study_id