Depression Treatment and Screening in Ovarian Cancer Patients
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
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
- 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).
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.
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Responses to Questionnaire Assessment of Depression Measures
Baseline assessment repeated at four months, and completion of first chemotherapy regimen for newly diagnosed ovarian, peritoneal, or fallopian tube cancer patients.
Eileen H. Shinn, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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