Clinical trial NCT03607474: Patient and Partner Perception After Remission of Cushing's Syndrome
Official title: Patient and Partner Perception After Remission of Cushing's Syndrome - Parathyroid 3 Cushing Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercorticism
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, aged more than 18, with hypercortisolism in remission for at least 1 year.

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.

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

Primary outcomes:
measure: assessment of quality of life
timeFrame: 30 minutes
measure: anxiety
timeFrame: 30 minutes
measure: body image
timeFrame: 30 minutes
measure: depression
timeFrame: 30 minutes
measure: coping
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Des Hopitaux de Marseille
state: Paca
Study officials:
affiliation: APHM DRIC
name: EMILIE GARRIDO PRADALIE
role: STUDY_DIRECTOR
References: