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Study Summary
No. ID02-258:.......Fallopian Tube; Ovary; Peritoneum......Eileen H. Shinn......Behavioral Science
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Study Summary Title
Study Summary
Number:
ID02-258
Study Title:Depression treatment and screening in ovarian cancer patients
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Physician New Patient Referral
Name:Eileen H. ShinnPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-0919
Contact us about clinical trials
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General Information
Disease Group:Fallopian Tube
Ovary
Peritoneum
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
All assessment timepoints will be scheduled to coincide with their clinic
appointments. However, if they are not able to come back in for a follow-up
assessment, we will be able to conduct interviews over the telephone.
Treatment
Agents:
NoneHome Care:A structured cognitive-behavioral journal will be given to the patient so that
she can use the workbook at home. Brief telephone therapy calls will
supplement the workbook.
Treatment Loc:MDACC + Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
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.
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Study Objectives / Outcomes
The specific aims of this study are:

1. To compare the effectiveness of five screening instruments against a gold standard in identifying cases of depression in ovarian, peritoneal, and fallopian tube cancer patients.
2. To determine the screening instrument, medical and demographic factors which predict depression in ovarian, peritoneal, and fallopian tube cancer patients four months after the beginning of their chemotherapy treatment.
3. To test the efficacy of an innovative cognitive-behavioral intervention to reduce depression using structured journal writing and brief telephone counseling, among ovarian, peritoneal, and fallopian tube cancer patients who are identified as depressed.
4. To describe patterns of care received by study participants who are identified as depressed.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:12/20/2002
Study Type:
Recruitment Status:Closed
Projected Accrual:Total accrual will be 588 ovarian, peritoneal, or fallopian tube cancer patients.
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

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Links
Registration Number: NCT00515372
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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