Depression Treatment and Screening in Ovarian Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Lance Armstrong Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00515372
First received: August 10, 2007
Last updated: November 20, 2013
Last verified: November 2013
  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:


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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention Group
Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.
Other: Telephone Counseling
Weekly phone calls lasting about 30 minutes.
Other Name: Survey
Usual Care Group
Lists of professional resources and referral recommendations will be provided.
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:

  1. 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.
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Eileen H. Shinn, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
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 20, 2013
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 July 10, 2014