Clinical Trials Directory

Trials / Completed

CompletedNCT03607474

Patient and Partner Perception After Remission of Cushing's Syndrome

Patient and Partner Perception After Remission of Cushing's Syndrome - Parathyroid 3 Cushing Study

Status
Completed
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERQuestionnaires 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
OTHERQuestionnaires of life quality for caregivers* the WhoQoL * The Beck II scale * HAD scale

Timeline

Start date
2018-03-30
Primary completion
2019-02-01
Completion
2023-05-26
First posted
2018-07-31
Last updated
2023-05-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03607474. Inclusion in this directory is not an endorsement.