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Biobehavioral Effects of Emotional Expression in Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Writing
Questionnaire
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Cancer focused on measuring Kidney Cancer, Renal Cell Carcinoma, Emotional Expression, Writing, Questionnaire, Survey

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Men or woman older than 18 years with stage I-IV renal cell carcinoma 2) Zubrod performance status of less than or equal to 2 3) have no serious intercurrent medical illness 4) read and speak English

Exclusion Criteria:

1) Score of 23 or below on the Mini-mental 2) History of primary or secondary immunodeficiency 3) Taking immunosuppressive drugs such as systemic corticosteroid 4) Patients who are undergoing a surgical procedure and do not sign the general tissue consent form 5) Patients with major psychiatric diagnoses or currently seeking psychological counseling.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Emotional Expression Writing

Neutral Writing

Arm Description

20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.

20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To learn how the expression of emotions affects quality of life, stress, and immune function.

Full Information

First Posted
July 19, 2007
Last Updated
August 26, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00505310
Brief Title
Biobehavioral Effects of Emotional Expression in Cancer
Official Title
Biobehavioral Effects of Emotional Expression in Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2002 (Actual)
Primary Completion Date
August 10, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: To evaluate an emotional expression intervention in patients with renal cancer. Researchers will determine the extent to which an emotional expression writing-based intervention enhances adjustment during the first 12 months following diagnosis and treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental health, and stress (subjective symptoms of distress, perceived stress, and mood). To determine the effects of an emotional expression writing-based intervention on immune function. The immune measures assessed in this study will include both general and autologous tumor-specific immune responses including cytotoxicity to K562 target cells; cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and type-2 cytokines using autologous tumor and polyclonal stimulants. To identify the psychosocial processes underlying the efficacy of the intervention.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
Kidney Cancer, Renal Cell Carcinoma, Emotional Expression, Writing, Questionnaire, Survey

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
705 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional Expression Writing
Arm Type
Experimental
Arm Description
20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
Arm Title
Neutral Writing
Arm Type
Experimental
Arm Description
20 minutes of writing on different topics at four different times. Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
Intervention Type
Behavioral
Intervention Name(s)
Writing
Intervention Description
20 minutes of writing on different topics at four different times.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.
Primary Outcome Measure Information:
Title
To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer.
Time Frame
8 Years
Secondary Outcome Measure Information:
Title
To learn how the expression of emotions affects quality of life, stress, and immune function.
Time Frame
8 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Men or woman older than 18 years with stage I-IV renal cell carcinoma 2) Zubrod performance status of less than or equal to 2 3) have no serious intercurrent medical illness 4) read and speak English Exclusion Criteria: 1) Score of 23 or below on the Mini-mental 2) History of primary or secondary immunodeficiency 3) Taking immunosuppressive drugs such as systemic corticosteroid 4) Patients who are undergoing a surgical procedure and do not sign the general tissue consent form 5) Patients with major psychiatric diagnoses or currently seeking psychological counseling.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Cohen, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24470003
Citation
Milbury K, Spelman A, Wood C, Matin SF, Tannir N, Jonasch E, Pisters L, Wei Q, Cohen L. Randomized controlled trial of expressive writing for patients with renal cell carcinoma. J Clin Oncol. 2014 Mar 1;32(7):663-70. doi: 10.1200/JCO.2013.50.3532. Epub 2014 Jan 27.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Biobehavioral Effects of Emotional Expression in Cancer

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