Collecting Information About Treatment Results for Patients With Cushing's Syndrome

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03364803

Collaborator

(none)

200

Enrollment

Locations

Anticipated Duration (Months)

28.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to follow participants with Cushing's syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.

Condition or Disease	Intervention/Treatment	Phase
Cushing's Disease Cushing Syndrome Cushing Disease	Other: Cushing's QoL (Quality of Life Questionnaire) Other: Nottingham Health Profile (NHP) Other: Hospital Anxiety and Depression Scale (HADS) Other: Perceived Stress Scale (PSS) Other: Barratt's Impulsivity Scale (BIS) Other: Beck Depression Inventory (BDI) Other: State-Trait Anxiety Inventory (STAI) Other: State Food Craving Questionnaire-State (FCQ-S) Other: Trait Food Craving Questionnaire-Trait (FCQ-T) Other: Visual Analogue Scale (VAS) Other: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Treatment Outcomes for Patients With Cushing's Syndrome: a Prospective Data Collection Study

Actual Study Start Date :

Nov 28, 2017

Anticipated Primary Completion Date :

Nov 28, 2024

Anticipated Study Completion Date :

Nov 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants with Cushing's Syndrome	Other: Cushing's QoL (Quality of Life Questionnaire) Cushing's QoL is a validated disease specific questionnaire consisting of 12 questions on a five-point Likert scale ranging from always to never. The total score ranges from 12 to 60, with a lower score indicating a greater negative impact on health related QoL. This is converted to a 0-100 scale, 0 indicating the worst and 100 indicating the best QoL Other: Nottingham Health Profile (NHP) NHP is used in patients to assess general health and quality of life. This assessment consists of 38 yes/no questions that are subdivided into six scales assessing impairments: pain (eight items), energy level (three items), sleep (five items), emotional reactions (nine items), social isolation (five items) and physical mobility (eight items). A higher score indicates more impairment Other: Hospital Anxiety and Depression Scale (HADS) HADS consists of 14 items pertaining to anxiety and depression, with each item measured on a four-point scale. Total scores for the anxiety and depression subscales range from 0 to 21. A higher score indicates greater symptomatology Other: Perceived Stress Scale (PSS) The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels. Other: Barratt's Impulsivity Scale (BIS) BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity Other: Beck Depression Inventory (BDI) BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity Other: State-Trait Anxiety Inventory (STAI) The STAI provides data to help distinguish between anxiety and depression. Other: State Food Craving Questionnaire-State (FCQ-S) The FCQ-S consists of 15 items assessing: desire to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement (reduction of negative affect) from eating, lack of control over eating, and (physiological) hunger; higher scores reflect stronger food craving. Participants respond, using a Likert-type scale, how much each item is true of them right now. Other: Trait Food Craving Questionnaire-Trait (FCQ-T) Trait food craving will be assessed with the Food Craving Questionnaire-Trait (FCQ-T). The FCQ-T consists of 39 items assessing: intentions/plans to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement from eating, lack of control over eating, preoccupation with food, (physiological) hunger, emotions preceding or following food cravings or eating, environmental cues that may elicit food cravings, negative emotions including guilt experienced as a consequence of food cravings, and/or indulging such cravings; higher scores again indicate higher trait craving. Individuals are asked to respond, using a Likert-type scale, how much each item is true of them in general. Other: Visual Analogue Scale (VAS) A validated visual analogue scale (VAS) questionnaire will be completed in the fasting state. The VAS consists of 100-mm lines with words anchored at each end describing extreme sensations of hunger, prospective consumption ("How much do you think you can eat?"), fullness, and satisfaction, as well as craving (sweet, salty, fatty or savory). Patients will be asked to make a vertical mark across the line corresponding to their feelings. Quantification will performed by measuring the distance from the left end of the line to the mark. Other: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant A validated questionnaire that assesses perceived subjective value attributed to expected/hypothetical foods and other primary reinforcers will be administered. This variant of this questionnaire was initially developed by Dr. Goldstein to assess 'liking' and 'wanting' of expected drug rewards for patients with cocaine addiction. The current assessment uses a modified version to assess 'liking' and 'wanting' for food.

Arm

Intervention/Treatment

Participants with Cushing's Syndrome

Other: Cushing's QoL (Quality of Life Questionnaire)

Cushing's QoL is a validated disease specific questionnaire consisting of 12 questions on a five-point Likert scale ranging from always to never. The total score ranges from 12 to 60, with a lower score indicating a greater negative impact on health related QoL. This is converted to a 0-100 scale, 0 indicating the worst and 100 indicating the best QoL

Other: Nottingham Health Profile (NHP)

NHP is used in patients to assess general health and quality of life. This assessment consists of 38 yes/no questions that are subdivided into six scales assessing impairments: pain (eight items), energy level (three items), sleep (five items), emotional reactions (nine items), social isolation (five items) and physical mobility (eight items). A higher score indicates more impairment

Other: Hospital Anxiety and Depression Scale (HADS)

HADS consists of 14 items pertaining to anxiety and depression, with each item measured on a four-point scale. Total scores for the anxiety and depression subscales range from 0 to 21. A higher score indicates greater symptomatology

Other: Perceived Stress Scale (PSS)

The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels.

Other: Barratt's Impulsivity Scale (BIS)

BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity

Other: Beck Depression Inventory (BDI)

BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity

Other: State-Trait Anxiety Inventory (STAI)

The STAI provides data to help distinguish between anxiety and depression.

Other: State Food Craving Questionnaire-State (FCQ-S)

The FCQ-S consists of 15 items assessing: desire to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement (reduction of negative affect) from eating, lack of control over eating, and (physiological) hunger; higher scores reflect stronger food craving. Participants respond, using a Likert-type scale, how much each item is true of them right now.

Other: Trait Food Craving Questionnaire-Trait (FCQ-T)

Trait food craving will be assessed with the Food Craving Questionnaire-Trait (FCQ-T). The FCQ-T consists of 39 items assessing: intentions/plans to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement from eating, lack of control over eating, preoccupation with food, (physiological) hunger, emotions preceding or following food cravings or eating, environmental cues that may elicit food cravings, negative emotions including guilt experienced as a consequence of food cravings, and/or indulging such cravings; higher scores again indicate higher trait craving. Individuals are asked to respond, using a Likert-type scale, how much each item is true of them in general.

Other: Visual Analogue Scale (VAS)

A validated visual analogue scale (VAS) questionnaire will be completed in the fasting state. The VAS consists of 100-mm lines with words anchored at each end describing extreme sensations of hunger, prospective consumption ("How much do you think you can eat?"), fullness, and satisfaction, as well as craving (sweet, salty, fatty or savory). Patients will be asked to make a vertical mark across the line corresponding to their feelings. Quantification will performed by measuring the distance from the left end of the line to the mark.

Other: Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant

A validated questionnaire that assesses perceived subjective value attributed to expected/hypothetical foods and other primary reinforcers will be administered. This variant of this questionnaire was initially developed by Dr. Goldstein to assess 'liking' and 'wanting' of expected drug rewards for patients with cocaine addiction. The current assessment uses a modified version to assess 'liking' and 'wanting' for food.

Outcome Measures

Primary Outcome Measures

Collection of data on Cushing's Syndrome participants before and over time after surgical, medication, and/or radiation therapy. [up to 10 years after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 14 or older
Active or treated Cushing's (due to pituitary, ectopic, or adrenal tumor)
The diagnosis of CS will be made by the PI, based on the below Endocrine Society guidelines, the patient's clinical presentation, and the PI's judgment.

° Diagnostic criteria for pituitary CD are according to the Endocrine Society guidelines and include: Elevated 24-hour urinary free cortisol (UFC), normal or elevated plasma ACTH, elevated midnight salivary cortisol levels, or classic dexamethasone suppression testing for CD (morning cortisol > 5 ug/dL after 1 mg overnight of classic 2-day low dose test) and a pituitary lesion on MRI. If patient does not have any of these results, pathology of ACTH tumor may confirm presence of disease.

For pituitary patients, if the patient demonstrates non-classic testing or no pituitary lesion is seen on MRI then petrosal sinus sampling or positive surgical pathology will be used to confirm pituitary source of Cushing's. Clinical or biochemical remission after surgery will also confirm pituitary source.
Ectopic Cushing's will be confirmed by petrosal sinus sampling and appropriate imaging tests, or positive surgical pathology.
Adrenal Cushing's will be confirmed by a suppressed plasma ACTH value and identification of an adrenal lesion on CT or MRI, or positive surgical pathology.
In lieu of MRI, surgical, or laboratory reports, physician's assessment note including mention of results will also be used as source for eligibility purposes.

Exclusion Criteria:

Patients with a diagnosis of iatrogenic Cushing's.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan - Kettering Cancer Center	New York	New York	United States	10021
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553