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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 30, 2008

Last Updated Date

February 15, 2009

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

psychological, physiological, immunological parameters [ Time Frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00726635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

Brief 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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Cancer of Cervix
Ovarian Cancer
Cancer of Endometrium

Intervention ^†

Behavioral: Cognitive intervention
Other: Control group
Other: psycho-physiological intervention

Study Arms / Comparison Groups

Active Comparator: Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
Experimental: Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
Experimental: Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

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

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Opher Caspi, MD PhD

972-39377995

ocaspi@clalit.org.il

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00726635

Responsible Party

Opher Caspi, MD PhD, Rabin Medical Center

Secondary IDs ^††

Study Sponsor ^†

Rabin Medical Center

Collaborators ^††

Academic College of Tel Aviv-Jaffa
Israel Cancer Association

Investigators ^†

Principal Investigator:

Opher Caspi, MD PhD

Director, Integrative Medicine - Rabin Medical Center

Information Provided By

Rabin Medical Center

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.