Ovarian Cancer Clinical Trial
Official title:
Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial
The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters
Surgery is considered one of the most stressful events in human life. Research indicates
that patients show high levels of stress from at least six days before surgery and up to a
week post the operation. Stress levels return to normalcy only after several weeks. Research
shows that psychological interventions given to women suffering from cancer can improve
their coping abilities and overall function, decreases stress levels, enhances adherence to
treatments,and increases quality of life and even life expectancy.
Women enrolled in this study will be divided into two groups: an experimental group and a
control group. Both groups will receive standard care. The control group will interact with
a nurse for one hour. The experimental group will receive one of two forms of psychological
intervention: either a cognitive intervention, or a psychophysiological intervention
(tailored to each woman).
Measurements and Instruments include: 1) Self-report questionnaires, such as:Profile of Mood
States (POMS-SF),Coping Inventory (COPE), Life Orientation Test Revised (LOT- R),Stress
Level Report, 2) Demographics, 3) Global assessment by the head nurse. 4)Physiological and
behavioral measures, such as: vital signs and use of medicine. 5)Hormonal and immunological
measures: levels of cortisol in saliva and plasma, levels of catecholamines in plasma,
salivary levels of IgA1, and peripheral blood NK cells and lymphocyte phenotyping.6)levels
of cytokines including IL-1,2,4,6,10,12, TNF-alpha, Interferon-gamma.
Time intervals for the collection of blood and saliva and the administration of the
questionnaires:
During the first week after being given the diagnosis and prior to the intervention:Blood &
saliva, Stress Level Report, POMS-SF, COPE, LOT-R
A day prior to surgery:Blood & saliva, Stress Level Report
On discharge from hospital:Blood & saliva, Stress Level Report
30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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