Biobehavioral Effects of Emotional Expression in Cancer
2 other identifiers
interventional
705
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2002
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedAugust 30, 2022
August 1, 2022
20 years
July 19, 2007
August 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the psychological and physiological benefits of an emotional expression program in patients with kidney cancer.
8 Years
Secondary Outcomes (1)
To learn how the expression of emotions affects quality of life, stress, and immune function.
8 Years
Study Arms (2)
Emotional Expression Writing
EXPERIMENTAL20 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.
Neutral Writing
EXPERIMENTAL20 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \) 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
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Snyder S, Milbury K, Wagner R, Cohen L. Words matter: The use of generic "you" in expressive writing in an oncology setting. J Health Psychol. 2024 Jan;29(1):42-51. doi: 10.1177/13591053231182218. Epub 2023 Jun 26.
PMID: 37358056DERIVEDMilbury 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.
PMID: 24470003DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Cohen, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 23, 2007
Study Start
August 21, 2002
Primary Completion
August 10, 2022
Study Completion
August 10, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08