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

This study has been completed.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01284751
First received: January 24, 2011
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Depression
Depressive Symptoms
Other: MDI - self-rating inventory

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Approximately one week before surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer patients
Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark.
Other: MDI - self-rating inventory
MDI with 12 questions to be completed approximately 1 week before surgery

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Department of Breast Surgery

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284751

Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Melissa V Hansen, MD Herlev Hospital
  More Information

Publications:
Responsible Party: M.D. Melissa Voigt Hansen, Herlev Hospital - Department of surgical gastroenterology
ClinicalTrials.gov Identifier: NCT01284751     History of Changes
Other Study ID Numbers: MVH-04, H-1-2010-FSP
Study First Received: January 24, 2011
Last Updated: May 11, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Danish Data Protection Agency

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Depressive Disorder, Major
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014