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Biobehavioral Effects of Emotional Expression in Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Biobehavioral Effects of Emotional Expression in Cancer


Patients in this study will already be scheduled for surgery/ablation, or for chemotherapy
and/or radiation treatment. Patients undergoing surgery/ablation will complete some
questionnaires about their mood and quality of life. These questionnaires will happen about
6 weeks after their procedure, during their scheduled visit to M.D. Anderson to follow-up
after their surgery. Patients scheduled to receive chemotherapy and/or radiation treatment
will complete the same questionnaires around the time of their new patient consult visit at
M.D. Anderson. They should take about 60 minutes to complete. About 8 teaspoons of blood
will be drawn to measure immune function.

Patients will then be randomly picked (as in the toss of a coin) to be in one of two groups.
One group will be the emotional expression writing group. The other group will be the
neutral writing group.

Patients in both groups will be asked to write for 20 minutes on different topics at four
different times. They will be asked to complete all assignments in their home. They will
choose four separate times when they would like to do the writing assignments and a research
assistant will prompt them with a phone call at those times. During these phone calls,
patients will complete a brief mood evaluation before the start of the writing session.
After 20 minutes, patients will receive another phone call to signal that they should stop
writing. A second mood assessment will also be given at this time. Patients will be
provided with a pre-addressed, stamped envelope for mailing each writing sample back to M.
D. Anderson the day after it is completed.

Patients will complete some questionnaires about their mood and quality of life
approximately 1 month, 4 months, and 10 months after their last writing assignment. They
should take about 60 minutes to complete. About 8 teaspoons of blood will then be taken
each time to measure immune function.

This is an investigational study. As many as 710 patients will be enrolled in this study.
All will be enrolled at M. D. Anderson.


Inclusion Criteria:



- Men or woman older than 18 years with stage I-IV renal cell carcinoma

- Zubrod performance status of less than or equal to 2

- Have no serious intercurrent medical illness

- Read and speak English

Exclusion Criteria:

- Score of 23 or below on the Mini-mental

- History of primary or secondary immunodeficiency

- Taking immunosuppressive drugs such as systemic corticosteroid

- Patients who are undergoing a surgical procedure and do not sign the general tissue
consent form

- Patients with major psychiatric diagnoses or currently seeking psychological
counseling.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer.

Outcome Time Frame:

8 Years

Safety Issue:

No

Principal Investigator

Lorenzo Cohen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID00-168

NCT ID:

NCT00505310

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Kidney Cancer
  • Renal Cell Carcinoma
  • Emotional Expression
  • Writing
  • Questionnaire
  • Survey
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030