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Depression Treatment and Screening in Ovarian Cancer Patients

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Telephone Counseling
Usual Care
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Depression, Telephone Counseling, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention Group

Usual Care Group

Arm Description

Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.

Lists of professional resources and referral recommendations will be provided.

Outcomes

Primary Outcome Measures

Patient Responses to Questionnaire Assessment of Depression Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2007
Last Updated
September 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Lance Armstrong Foundation, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00515372
Brief Title
Depression Treatment and Screening in Ovarian Cancer Patients
Official Title
Depression Treatment and Screening in Ovarian Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2002 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Lance Armstrong Foundation, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Study Participation: If you agree to take part in this study, you will fill out a questionnaire, complete an interview (called a SCID interview), and information will be collected from your medical record. For the questionnaire, you will answer questions about your mood, ability to cope with cancer, thoughts about cancer, and demographic information (such as your age and race). It should take between 30 and 40 minutes to complete the questionnaire. For the SCID interview (which may be conducted during your routine visit at M. D. Anderson or by telephone), a trained interviewer will ask you questions related to the degree of depression you may be experiencing. It should take between 30 and 40 minutes to complete the SCID interview. The study staff will also show you TAT cards, which are standardized psychological testing cards, and ask you to give responses to the cards. Information collected from your medical record will include the cancer stage, if the disease has gotten worse, treatment, and side effects. This information will help researchers learn how specific treatments affect patients. You may also be asked to have an informal interview on your personal experience about matters not related to depression. Information learned from this interview may need to be addressed in order to help you cope with your personal cancer experiences (such as communicating with your study doctor and study staff, financial counseling, and spiritual guidance). If you are not found to be eligible for the intervention group, you will be contacted again in 4 months to complete a second questionnaire and SCID interview. Both will be the same as the first questionnaire and SCID interview, except that the questionnaire will have additional questions about the type of psychosocial help you may have received outside of this research study during the 4-month period. Study Group Randomization: If your answers to the first questionnaire show that you might benefit from psychosocial support, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups (an intervention group or an enhanced standard care group). Intervention Group: If you are assigned to the intervention group, you will receive intervention plus enhanced standard care that is described below. For the intervention, you will have 10 telephone calls by a trained psychologist under the supervision of a licensed psychiatrist. The psychologist will discuss with you and teach you cognitive-behavioral techniques. These techniques will show you ways to relax, how to schedule physical activities, and how to identify and counter negative thoughts. You will also receive a journal to write down ideas on how to practice fighting depression. These intervention calls will last about 30 minutes each time, and will occur once a week (almost every week). Standard Care Group: If you are assigned to the enhanced standard care group, you will be informed of the results of the analysis of your first questionnaire and provided with a list of professional resources and referral recommendations for psychosocial counseling. Your treating doctor and/or regular doctor will also be informed of these results as well. After 4 months in this group, you will be able to receive the intervention as described above. Additional Information: In order to check for quality control (to see if the intervention and SCID interview have been appropriately done), a random sample of telephone counseling sessions (from the intervention group) will be tape recorded, and a random sample of interviews (the SCID interviews) will be tape recorded and/or videotaped. Before any information is tape recorded and/or videotaped, you will be asked for your permission. The tape recording and/or videotaping will be done by members of study staff. No identifying information (such as your name and medical record number) will be recorded on the audiotape and/or videotape. The audiotape and/or videotape will only be labeled with study ID numbers. Length of Study: If your answers to the first questionnaire do not show that you might benefit from psychosocial support, your participation will be over (in about 4 months) after you have completed the follow-up questionnaire and SCID interview. If you are assigned to the intervention, your participation will be over (in about 4 months) once you have completed the 10 weekly intervention sessions. If you are assigned to the standard care group, your participation will be over in about 4 months, or about 8 months if you are able to also take part in the intervention once you have completed your participation in the standard care group. This is an investigational study. Up to 588 patients will take part in this study. All will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, Depression, Telephone Counseling, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Weekly phone calls lasting about 30 minutes. Lists of professional resources and referral recommendations will be provided.
Arm Title
Usual Care Group
Arm Type
Other
Arm Description
Lists of professional resources and referral recommendations will be provided.
Intervention Type
Other
Intervention Name(s)
Telephone Counseling
Other Intervention Name(s)
Survey
Intervention Description
Weekly phone calls lasting about 30 minutes.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Lists of professional resources and referral recommendations will be provided.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen H. Shinn, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Depression Treatment and Screening in Ovarian Cancer Patients

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