Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	18 to 70	Other	0014-08-RMC NCT00726635

Trial Description

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

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

• Woman with ovarian, cervical or endometrial cancer/tumor

• Women who speak Hebrew

• Women who sign the consent form

Exclusion Criteria:

• Women who have received neoadjuvant treatment

• Women suffering from any form of depression, anxiety or schizophrenia

• Women suffering from autoimmune or infectious diseases

• Women taking medications which have immunological effects (steroids ,beta-blockers)

• Women suffering from dementia or concentration problems

Trial Contact Information

Trial Lead Organizations/Sponsors

Rabin Medical Center - Beilinson Campus

Opher Caspi, MD PhD

Principal Investigator

Opher Caspi, MD PhD		Ph: 972-39377995
		Email: ocaspi@clalit.org.il

Israel
	Petah Tikva
	Rabin Medical Center - Beilinson Campus
		Opher Caspi, MD PhD	Ph: 972-3937795
			Email: ocaspi@clalit.org.il
		Mira Livingstone, B.A	Ph: 972-542562083
			Email: mira.livingstone@gmail.com
		Opher Caspi, MD PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00726635
Information obtained from ClinicalTrials.gov on March 18, 2009