Depression Treatment and Screening in Ovarian Cancer Patients

This study is ongoing, but not recruiting participants.

First Received on August 10, 2007. Last Updated on November 11, 2011 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	Lance Armstrong Foundation National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00515372

Purpose

The goal of this behavioral research study is to find a quick and effective way to identify depression in patients with ovarian, peritoneal, or fallopian tube cancer. Another goal of this study is to compare an intervention program with "enhanced" standard care to see which may be more effective in improving quality of life for these patients.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Other: Telephone Counseling Other: Usual Care	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Depression Treatment and Screening in Ovarian Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Depression Ovarian Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Patient Responses to Questionnaire Assessment of Depression Measures [ Time Frame: Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients. ] [ Designated as safety issue: No ]

Estimated Enrollment:	588
Study Start Date:	December 2002
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention Group	Other: Telephone Counseling Weekly phone calls lasting about 30 minutes. Other Name: Survey
Usual Care Group	Other: Usual Care Lists of professional resources and referral recommendations will be provided.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women are eligible if they a) are on active treatment, but not at the end of a treatment regimen) for newly diagnosed, recurrent, or persistent ovarian cancer or peritoneal cancer or fallopian tube cancer (any stage) c) are at least 18 years of age; d) speak and read English at a 7th grade level; e) are oriented to time, person, and place; g) have a Zubrod performance status (49) of 0-2; and h) provide informed consent.
They are eligible for the pilot intervention phase of the study if they have a diagnosis of major depressive disorder, dysthymic disorder, adjustment disorder with depressed mood, minor depression, major depression in partial remission, or recurrent brief depressive disorder.

Exclusion Criteria:

1) They will be excluded from this phase of the study if they are diagnosed as having a bipolar disorder or psychosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515372

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Lance Armstrong Foundation

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Eileen H. Shinn, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00515372 History of Changes
Other Study ID Numbers:	ID02-258
Study First Received:	August 10, 2007
Last Updated:	November 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer

Depression
Telephone Counseling
Quality of Life

Additional relevant MeSH terms:

Depression
Depressive Disorder
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on May 22, 2012