We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Depression Treatment and Screening in Ovarian Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515372
First Posted: August 13, 2007
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lance Armstrong Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  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
Intervention Model: Parallel Assignment
Masking: None (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. ]

Estimated Enrollment: 588
Study Start Date: December 2002
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515372


Locations
United States, Texas
University of Texas 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:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00515372     History of Changes
Other Study ID Numbers: ID02-258
NCI-2012-02127 ( Registry Identifier: NCI CTRP )
1CF2002-0000832 HM 01 ( Other Grant/Funding Number: Lance Armstrong Foundation )
K07CA093512-01A2 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2007
First Posted: August 13, 2007
Last Update Posted: November 29, 2016
Last Verified: November 2016

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
Ovarian Neoplasms
Fallopian Tube Neoplasms
Behavioral Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases