NCT00505310

Biobehavioral Effects of Emotional Expression in Cancer

Completed NA Last updated 30 August 2022

What this trial tests

NA trial testing Writing in Kidney Cancer in 705 participants. Completed in 10 August 2022.

Timeline

21 August 2002

Primary endpoint
10 August 2022

10 August 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	705
Start date	21 August 2002
Primary completion	10 August 2022
Estimated completion	10 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Writing
• Questionnaire

Conditions studied

• Kidney Cancer — all drugs for Kidney Cancer →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Kidney Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized controlled trial of expressive writing for patients with renal cell carcinoma.
   Milbury K, Spelman A, Wood C, Matin SF, et al · · 2014 · cited 43× · PMID 24470003 · DOI 10.1200/jco.2013.50.3532
2. Examination of moderators of expressive writing in patients with renal cell carcinoma: the role of depression and social support.
   Milbury K, Lopez G, Spelman A, Wood C, et al · · 2017 · cited 19× · PMID 27145447 · DOI 10.1002/pon.4148
3. Words matter: The use of generic "you" in expressive writing in an oncology setting.
   Snyder S, Milbury K, Wagner R, Cohen L. · · 2024 · cited 1× · PMID 37358056 · DOI 10.1177/13591053231182218
4. 522 Inflammatory biomarkers in heart failure family caregivers: Associations of TNF-α and adiponectin with cardiovascular risk
   Herring C, Higgins M, Dunbar S, Butts B. ·
5. 519 Clinical translation of quantitative ultrasound for nail disease: Bridging imaging biophysics and dermatology
   Golbasi N, Hoerig C, Lipner S, Mamou J. ·
6. 520 Integrating patient voices to enhance patient-reported outcomes: A human-guided machine learning approach to analyzing health narratives
   Amezquita-Castro B. ·
7. 523 Hospital capacity strain and delays in antimicrobial redosing in sepsis
   Sheehan K, Kowalkowski M, Palakshappa J. ·