Trial Information

Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer

Study Participation:

If you agree to take part in this study, medical and demographic information will be
collected from your medical record and/or by asking you in person when you come to the
clinic for your routine visits. This information includes your date of birth, medical
history, occupation, marital status, race, household income, and number of children and/or
other dependents (if any).

On Day 1 of your study participation, you will be interviewed by a research staff member.
In this interview, you will be asked about your health and any symptoms related to the
cancer and/or cancer treatment. You will also be asked for the best way of contacting you.
This interview should take about 30 minutes to complete. After the interview, you will
complete a set of 5 questionnaires. In total, the questionnaires should take about 15
minutes to complete. You will repeat these same 5 questionnaires on Day 1 of each of your
chemotherapy cycles. The questionnaires include the following:

- Questionnaire 1 (The Short Form 12) asks about your physical and emotional health, any
pain, social functioning, and general health. This information will help researchers
keep track of how you feel and how well you are able to do your usual activities.

- Questionnaire 2 (The Functional Assessment of Cancer Therapy) asks about the symptoms
of cancer and how these symptoms may affect your physical, social, and emotional
well-being.

- Questionnaire 3 (Medical Outcomes Study) asks about your sexual functioning.
Researchers believe this information is important in understanding how health problems
affect people's lives.

- Questionnaire 4 (The Functional Assessment of Cancer Therapy/Neurotoxicity
questionnaire) asks whether or not you have had any numbness and/or tingling in your
hands and/or feet. This numbness/tingling can occur as a side effect of some
chemotherapy drugs that are commonly given to patients with ovarian cancer.

- Questionnaire 5 (The Memorial Symptom Assessment Scale) asks about the symptoms of
ovarian cancer and the side effects of ovarian cancer treatment.

In addition, you will also be asked to complete the following questionnaires for each cycle
of chemotherapy:

- Questionnaire 6 (The Productivity and Activity Impairment General Health questionnaire)
asks about how you feel your health status may have affected your and/or your primary
caregiver's "productivity" (your ability to perform normal activities) at work and at
home.

- Questionnaire 7 (The European Quality of Life instrument) asks a few questions about
your health status on that particular day. It also asks you to rate your health status
by marking on a scale how good or bad your health is on that day.

- Questionnaire 8 is a diary in which you will record all medical costs (such as any
emergency room visits, hospitalizations, doctor's visits, and medications) that you
have had to pay for in the last week.

- Questionnaire 9 is a diary in which you will record your treatment-related costs that
are not medical (such as travel, child care costs, parking fees, and gasoline).

You can bring the completed Questionnaires 6-9 with you when you return for your next
follow-up visit, email, fax or mail them back to the clinic before your next visit. If
necessary, you may complete them over the phone instead. In total, Questionnaires 6-9
should take about 7 minutes to complete each time.

Questionnaire Content:

Your responses on these questionnaires will not be shared with the doctor who is treating
you for cancer. If you feel you need a doctor's opinion about anything that is asked about
in these questionnaires (such as cancer symptoms or mental or emotional difficulties),
please contact your doctor.

If your questionnaire responses show that you may be having emotional difficulties or
depression, you will be provided with names of mental health providers in case you would
like to receive a mental health screening.

Caregivers' Participation:

Your caregiver will also be asked to complete Questionnaire 6 for each cycle of chemotherapy
you receive. Specifically, the caregiver will answer questions about how he or she feels
your health status may have affected his or her productivity at work and at home.

Your questionnaires will be used for research purposes only, and your responses will not be
shared with the caregiver. Likewise, the caregiver's responses will not be shared with you.
You will receive separate return envelopes for mailing back your questionnaires separately
from the caregiver's.

Length of Study Participation:

This is a long-term study, and you will remain "on study" for as long as you and the
caregiver agree to keep filling out the questionnaires. If you stop receiving treatment for
the cancer, your and the caregiver's participation in this study will be over.

This is an investigational study. You will receive stamped, self-addressed envelopes for
mailing the questionnaires back to the clinic.

Up to 43 patients and 43 caregivers will take part in this study. All will be enrolled at
M. D. Anderson.