CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 705 enrolled
Drug / intervention
Writing +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00505310
NCT00505310N/ACompleted

Biobehavioral Effects of Emotional Expression in Cancer

M.D. Anderson Cancer Center·interventional·Posted Jul 23, 2007·Updated Aug 30, 2022

In Brief

A clinical study evaluating Writing and Questionnaire for Kidney Cancer. Completed, enrolled 705 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2007
Enrollment StartAug 21, 2002
Primary CompletionAug 10, 2022
TodayJul 1, 2026
Enrollment to primary: 20.0 yearsPosted 18.9 years ago

Interventions

Writingbehavioral

20 minutes of writing on different topics at four different times.

Questionnairebehavioral

Questionnaires about mood and quality of life completed 1 month, 4 months, and 10 months after the last writing assignment.