Patient and Partner Perception After Remission of Cushing's Syndrome

NCT ID: NCT03607474

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2023-05-26

Brief Summary

Hypercortisolism leads to long term physical and cognitive sequelae. This also holds true for quality of life, even several years after remission. This altered quality of life, highly subjective, is however, badly evaluated by the family of the patient. This could lead to misunderstanding, avec worsen the general physical and mental health of the patient. To our knowledge, this theoretical difference of perception has never been evaluated up to now.

The aim of our study is to evaluate the difference of perception of the quality of life and body image between patients in remission of hypercortisolism, and their caregivers. Secondary objectives will be to evaluate the quality of life of the caregivers, the coping strategies, and the depression/anxiety parameters of both the patient and the caregiver. Patients and methods: the study is Observative, prospective and non-randomized. Inclusion criteria will be patients, aged more than 18, with hypercortisolism in remission for at least 1 year. Self-questionnaires on quality of life, body image, coping, depression and anxiety will be provided to the patient and his/her caregiver. Fulfilling will be blind between the patient and his/her caregiver. Inclusion period will be 12 months.

Results will be compared between the patient and his/her caregiver. Expected results: investigators anticipate that some caregivers will have a different perception of the general physical and mental condition as stated by the patient. The first time that the quality of life of the caregiver would be also altered.

This original project might lead to modify the management of Cushing's syndrome, by considering both the patient and his/her caregiver on a long term basis after remission.

Detailed Description

Introduction: Hypercortisolism leads to long term physical and cognitive sequelae. This also holds true for quality of life, even several years after remission. This altered quality of life, highly subjective, is however, badly evaluated by the family of the patient. This could lead to misunderstanding, avec worsen the general physical and mental health of the patient. To our knowledge, this theoretical difference of perception has never been evaluated up to now. Aims: The aim of our study is to evaluate the difference of perception of the quality of life and body image between patients in remission of hypercortisolism, and their caregivers. Secondary objectives will be to evaluate the quality of life of the caregivers, the coping strategies, and the depression/anxiety parameters of both the patient and the caregiver. Patients and methods: the study is Observative, prospective and non-randomized. Inclusion criteria will be patients, aged more than 18, with hypercortisolism in remission for at least 1 year. Self-questionnaires on quality of life, body image, coping, depression and anxiety will be provided to the patient and his/her caregiver. Fulfilling will be blind between the patient and his/her caregiver. Inclusion period will be 12 months. Results will be compared between the patient and his/her caregiver. Expected results: investigators anticipate that some caregivers will have a different perception of the general physical and mental condition as stated by the patient. The first time that the quality of life of the caregiver could be also altered. Perspectives: This original project might lead to modify the management of Cushing's syndrome, by considering both the patient and his/her caregiver on a long term basis after remission.

Conditions

Hypercorticism

Study Design

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

Study Groups

Couple (Patients and caregivers)

Patient in remission of hypercortisolism Caregivers will be the spouse or, failing that, a person close to the patient, who has been in regular contact with the patient since taking care of him.

Questionnaires of life quality for patients Questionnaires of life quality for caregivers

Questionnaires of life quality for patients

Intervention Type: OTHER

• the WhoQoL
• a specific scale of Cushing's syndrome
• The Beck II scale
• HAD scale
• Rosenberg questionnaire
• Stunkard, Sorensen and Schlusinger (1983) figurines
• Brief Cope scale

Questionnaires of life quality for caregivers

Intervention Type: OTHER

• the WhoQoL
• The Beck II scale
• HAD scale

Interventions

Questionnaires of life quality for patients

• the WhoQoL
• a specific scale of Cushing's syndrome
• The Beck II scale
• HAD scale
• Rosenberg questionnaire
• Stunkard, Sorensen and Schlusinger (1983) figurines
• Brief Cope scale

Intervention Type: OTHER

Questionnaires of life quality for caregivers

• the WhoQoL
• The Beck II scale
• HAD scale

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject, male or female over 18
• Subject presenting a hypercortisolism in remission or controlled by a drug treatment for more than one year.
• Subject with a good understanding of the French language
• Non-institutionalized subject
• Subject whose informed consent could be obtained

Exclusion Criteria

• Minor subject or over 80 years
• Subject presenting hypercortisolism in remission for more than 20 years
• Major cognitive impairment that does not allow answering a questionnaire
• Genetic syndrome responsible for hypercortisolism
• Mixed adenoma whose corticotropic share is responsible for hypercortisolism
• Pituitary carcinoma
• Subject refusing to participate in the study
• Subject having no close
• Subject whose relative refuses to answer the questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EMILIE GARRIDO PRADALIE

Role: STUDY_DIRECTOR

APHM DRIC

Locations

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, France

Countries

France

Other Identifiers

2018-38

Identifier Type: -

Identifier Source: org_study_id