NCT00726635

The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies

Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cancer of Cervix
• Ovarian Cancer
• Cancer of Endometrium

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive intervention	The intervention will last one hour and will include cognitive technique (self-talk). The technique will be demonstrated to the woman, practiced with her, and taped so as to encourage further practice at home.
OTHER	Control group	A one hour conversation with a nurse
OTHER	psycho-physiological intervention	The intervention will last an hour and will include a psycho-physiological intervention (relaxation and guided imagery). The technique will be demonstrated to the woman, practiced with her, and taped so as to assure further practice at home

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-08-01
• Last updated: 2009-02-17

Locations

1 site across 1 country: Israel