Biobehavioral Effects of Emotional Expression in Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505310
First received: July 19, 2007
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Kidney Cancer
Behavioral: Writing
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Biobehavioral Effects of Emotional Expression in Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To learn how the expression of emotions affects quality of life, stress, and immune function. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 710
Study Start Date: August 2002
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emotional Expression Writing
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.
Behavioral: 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.
Other Name: Survey
Experimental: Neutral Writing
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.
Behavioral: 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.
Other Name: Survey

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505310

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505310     History of Changes
Other Study ID Numbers: ID00-168, NCI-2012-02100
Study First Received: July 19, 2007
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Kidney Cancer
Renal Cell Carcinoma
Emotional Expression
Writing
Questionnaire
Survey

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 25, 2014