Depression Treatment and Screening in Ovarian Cancer Patients

Brief Title

Depression Treatment and Screening in Ovarian Cancer Patients

Official Title

Depression Treatment and Screening in Ovarian Cancer Patients

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Patient Responses to Questionnaire Assessment of Depression Measures

Condition

Ovarian Cancer

Intervention

Telephone Counseling

Study Arms / Comparison Groups

 Intervention Group

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

December 20, 2002

Completion Date

December 31, 2027

Primary Completion Date

December 31, 2027

Eligibility 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.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eileen H. Shinn, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00515372

Organization ID

ID02-258

Secondary IDs

NCI-2012-02127

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Lance Armstrong Foundation

Study Sponsor

Eileen H. Shinn, PhD, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

September 2022