Depression Treatment and Screening in Ovarian Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
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 19, 2012
Last verified: November 2012
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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 2014 (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:
- 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
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 19, 2012 |
| 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 21, 2013