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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00505310 |
The proposed study will assess the psychological and physiological benefits of an emotional expression intervention in patients with renal cancer. Patients will be randomly assigned to an emotional expression writing group or to a neutral writing group. This study will also evaluate the extent to which psychosocial factors mediate the intervention program and predict patients' recovery and adjustment to treatment. Potential mediators include level of cognitive processing, social networks/interactions, and sense of coherence and ability to find meaning in the illness experience.
Specific objectives of the proposed research are:
Condition | Intervention |
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Kidney Cancer |
Behavioral: Emotional Expression Writing Behavioral: Neutral Writing Behavioral: Questionnaire |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Biobehavioral Effects of Emotional Expression in Cancer |
Estimated Enrollment: | 710 |
Study Start Date: | August 2002 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Emotional Expression Writing
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Behavioral: Emotional Expression Writing
20 minutes of writing on different topics at four different times.
Behavioral: Questionnaire
Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
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2: Experimental
Neutral Writing
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Behavioral: Neutral Writing
20 minutes of writing on different topics at four different times.
Behavioral: Questionnaire
Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion:
Contact: Lorenzo Cohen, PhD | 713-745-4260 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Lorenzo Cohen, PhD |
Principal Investigator: | Lorenzo Cohen, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Lorenzo Cohen, PhD/Professor ) |
Study ID Numbers: | ID00-168 |
Study First Received: | July 19, 2007 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00505310 |
Health Authority: | United States: Institutional Review Board |
Kidney Cancer Renal Cell Carcinoma Emotional Expression |
Writing Questionnaire Survey |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |