The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

Completed

• Conditions: Depression; Depressive Symptoms
• Interventions: Other: MDI - self-rating inventory

• Registration Number: NCT01284751
• Lead Sponsor: Herlev Hospital

Brief Summary

The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.

Detailed Description

The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.

Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
• ASA I-III

Exclusion Criteria

• Planned or ongoing preoperative chemotherapy
• Known and treated sleep apnea syndrome
• Insulin treated diabetes mellitus
• Known or previous treated depressive illness or bipolar disorder
• Known autoimmune disease
• Incompensated cirrhosis
• Other previous or ongoing cancer
• Known medically treated sleep disorder (insomnia, restless legs etc)
• Shift-work or night-work
• Daily alcohol intake of more than 5 units
• Preoperative treatment with psychopharmacological drugs, opioids or anxiolytics
• Predicted bad compliance
• Pregnant or breast feeding
• Preoperative MMSE score less than 24

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients	MDI - self-rating inventory	Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	Approximately one week before surgery	Total score on the Major Depression Inventory. When used as a diagnostic instruemtn patients witll according to the ICD-10 algorhythym be classified as mild, moderate or severe depression or no depression.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark