HypercorticismCUSHINGNCT03607474
Patient and Partner Perception After Remission of Cushing's Syndrome
An observational study of Hypercorticism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercorticism
- What is being tested?
- Questionnaires of life quality for patients and Questionnaires of life quality for caregivers
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2018to 26 May 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients, aged more than 18, with hypercortisolism in remission for at least 1 year.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject refusing to participate in the study
- Subject having no close
- Subject whose relative refuses to answer the questionnaires
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
Official title: Patient and Partner Perception After Remission of Cushing's Syndrome - Parathyroid 3 Cushing Study
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.
Read more
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.
Read the 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
- Being tested
- Questionnaires of life quality for patients, Questionnaires of life quality for caregivers
- Medical subject headings
- Adrenocortical Hyperfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires of life quality for patientsOther
- 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 caregiversOther
- the WhoQoL
- The Beck II scale
- HAD scale
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaires of life quality for patients; Other: Questionnaires of life quality for caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of quality of life
the World health organisation Quality Of Life ( WHOQOL) is a specific scale of Cushing's syndrome studying: Physical health (Activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, Work Capacity) Psychological (Bodily image and appearance, Negative feelings, Positive feelings, Self-esteem, Spirituality / Religion / Personal beliefs, Thinking, learning, memory and concentration Social relationships (Personal relationships, Social support, Sexual activity) Environment (Financial resources, Freedom, physical safety and security, Health and social care, Home environment, Opportunities for acquiring new information and skills, Participation in and opportunities for recreation / leisure activities, Physical environment, Transport) intensity of items is rated from not at all (=0), a little (=1), moderately (=2), very much (=3) to extremely (=4).
Measured: 30 minutes
anxiety
using the Hospital Anxiety and Depression scale The HAD scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21)
0- never
- sometimes
- Often enough
- very often
Measured: 30 minutes
body image
using the Scale of Estime of Self of Rosenberg:
10 questions for which it must be indicated how true it is (rated from 1 to 4). Then, simply add your scores to questions 1, 2, 4, 6 and 7. For questions 3, 5, 8, 9 and 10, the quotation is reversed, that is to say, it is necessary to count 4 if you surround the number 1, 3 if you surround the 2, 2 if you surround the 3 and 1 if you surround the 4.
results: If score below 25, self-esteem is very low. Work in this area seems desirable. If score between 25 and 31, self-esteem is low. Work in this area would be beneficial. If score between 31 and 34, self-esteem is average. If score between 34 and 39, your self-esteem is strong. If score above 39, self-esteem is very high and you tend to be strongly affirmed.
Measured: 30 minutes
depression
The Beck Depression Inventory-II (BDI-II):
21-item self-report multiple-choice inventory (10 minutes to complete) Widely used indicator of the severity of depression 21 items of symptoms and attitudes graduated from 0 to 3 reflecting the severity of the symptom.
The maximum total score is 63. score indicates 0-13 minimal depression 14-19: mild depression 20-28 moderate depression 29-63 severe depression
Measured: 30 minutes
coping
Stunkard, Sorensen and Schlusinger (1983) figurines that measure the visual representation of the body The Stunkard scale consists of 9 silhouette figures that increase gradually in size from very thin (a value of 1) to very obese (a value of 9) Self body size is the number of the figure selected by participants in response to the prompt: "Choose the figure that reflects how you think you look." Ideal body size is the number of the figure chosen in response to the prompt: "Choose your ideal figure." For self body size and ideal body size, dummy variables were created for the underweight, normal weight, overweight, and obese body size categories.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start30 Mar 2018
- Primary completion1 Feb 2019
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercorticismStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM DRIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607474
- Sponsor's protocol ID
- 2018-38
- Acronym
- CUSHING
- Status last verified
- May 2023
- First submitted
- 28 Jun 2018
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Partner Perception After Remission of Cushing's Syndrome - Parathyroid 3 Cushing Study
- ClinicalTrials.gov ID
- NCT03607474
- Acronym / sponsor ID
- CUSHING / 2018-38
- Conditions
- Hypercorticism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couple (Patients and caregivers) | – | Other: Questionnaires of life quality for patients, Other: Questionnaires of life quality for caregiversPatient 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients, aged more than 18, with hypercortisolism in remission for at least 1 year.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Couple (Patients and caregivers) |
| Questionnaires of life quality for caregivers* the WhoQoL * The Beck II scale * HAD scale | Other | Couple (Patients and caregivers) |
Primary outcome
assessment of quality of life
Time frame: 30 minutes
the World health organisation Quality Of Life ( WHOQOL) is a specific scale of Cushing's syndrome studying: Physical health (Activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, Work Capacity) Psychological (Bodily image and appearance, Negative feelings, Positive feelings, Self-esteem, Spirituality / Religion / Personal beliefs, Thinking, learning, memory and concentration Social relationships (Personal relationships, Social support, Sexual activity) Environment (Financial resources, Freedom, physical safety and security, Health and social care, Home environment, Opportunities for acquiring new information and skills, Participation in and opportunities for recreation / leisure activities, Physical environment, Transport) intensity of items is rated from not at all (=0), a little (=1), moderately (=2), very much (=3) to extremely (=4).
anxiety
Time frame: 30 minutes
using the Hospital Anxiety and Depression scale The HAD scale is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21) 0- never 1. sometimes 2. Often enough 3. very often
body image
Time frame: 30 minutes
using the Scale of Estime of Self of Rosenberg: 10 questions for which it must be indicated how true it is (rated from 1 to 4). Then, simply add your scores to questions 1, 2, 4, 6 and 7. For questions 3, 5, 8, 9 and 10, the quotation is reversed, that is to say, it is necessary to count 4 if you surround the number 1, 3 if you surround the 2, 2 if you surround the 3 and 1 if you surround the 4. results: If score below 25, self-esteem is very low. Work in this area seems desirable. If score between 25 and 31, self-esteem is low. Work in this area would be beneficial. If score between 31 and 34, self-esteem is average. If score between 34 and 39, your self-esteem is strong. If score above 39, self-esteem is very high and you tend to be strongly affirmed.
depression
Time frame: 30 minutes
The Beck Depression Inventory-II (BDI-II): 21-item self-report multiple-choice inventory (10 minutes to complete) Widely used indicator of the severity of depression 21 items of symptoms and attitudes graduated from 0 to 3 reflecting the severity of the symptom. The maximum total score is 63. score indicates 0-13 minimal depression 14-19: mild depression 20-28 moderate depression 29-63 severe depression
coping
Time frame: 30 minutes
Stunkard, Sorensen and Schlusinger (1983) figurines that measure the visual representation of the body The Stunkard scale consists of 9 silhouette figures that increase gradually in size from very thin (a value of 1) to very obese (a value of 9) Self body size is the number of the figure selected by participants in response to the prompt: "Choose the figure that reflects how you think you look." Ideal body size is the number of the figure chosen in response to the prompt: "Choose your ideal figure." For self body size and ideal body size, dummy variables were created for the underweight, normal weight, overweight, and obese body size categories.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM DRIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercorticism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of quality of life (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.