IRB Number:

2314-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to learn if carefully planned visits with members of a health care team can improve the quality of life (QOL) and mood issues of the patient and their caregiver compared to standard medical care.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 receiving active treatment for their cancer may be eligible to participate in this research study.

What is Involved With this Study?

You will be randomly assigned (as in the flip of a coin) to either a 6-session multidisciplinary structured intervention and telephone follow-up for 6 months (Group A) or to standard medical care (Group B). Your quality of life (QOL) and mood will be measured by several questionnaires at baseline, weeks 4, 27 and 52. Instruction and education is necessary to obtain benefit from this intervention, and therefore, your concentration level will be used as an entry criterion. You must have a caregiver who is willing to attend 4 of the 6 sessions with you if you are randomized to Group A.

Patients in both study groups will receive the standard medical care given to patients with your type of cancer. You may also use resources available within and outside the Mayo Clinic such as chaplaincy services or meeting with members of the faith community, education materials, the Internet, libraries, support groups, social services, hospice programs, and other.

Patients in both study groups will be asked to fill out forms with questions about their quality of life (mental, emotional, physical, social and spiritual well being). This will take 15-30 minutes and will take place during scheduled visits to the clinic, or will be mailed to you at your home. Because quality of life may change over time, you will be asked to fill out the same form(s) a number of times: at the start of the study, at 4 weeks (or after the 6 sessions for patients in Group A), at 27 & 52 weeks after starting the study.

Patients in Group A will be scheduled to go to 6, 90-minute sessions within 3 weeks. During these visits you will meet with one or more members of a health care team to learn and talk about things such as coping, stress management, depression, substance usage, problem solving, grief, guilt, hope, physical activity, goal setting, religious beliefs, death and afterlife, relationships, body image and sexuality, relaxation, and other topics. You will also be called on the telephone by the study team for 6 months, who will review topics presented in the sessions with the health care team.

All participants will be contacted at 6 months and at one year to again complete the study forms on mood and quality of life.

How long will the Study run?

You will be in the study for up to one year.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 03/28/2008