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

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ClinicalTrials.gov Identifier: NCT00726635
Recruitment Status : Unknown
Verified July 2008 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : August 1, 2008
Last Update Posted : February 17, 2009
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Cancer of Cervix Ovarian Cancer Cancer of Endometrium Behavioral: Cognitive intervention Other: Control group Other: psycho-physiological intervention Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
Other: Control group
A one hour conversation with a nurse
Experimental: 2
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
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 Name: Tailored cognitive intervention
Experimental: 3
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
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
Other Name: tailored psycho-physiological intervention

Outcome Measures

Primary Outcome Measures :
  1. psychological, physiological, immunological parameters [ Time Frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726635

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

Rabin Medical center Recruiting
Petah Tikva, Israel, 49100
Contact: Opher Caspi, MD PhD    972-3937795    ocaspi@clalit.org.il   
Contact: Mira Livingstone, B.A    972-542562083    mira.livingstone@gmail.com   
Principal Investigator: Opher Caspi, MD PhD         
Sponsors and Collaborators
Rabin Medical Center
Academic College of Tel Aviv-Jaffa
Israel Cancer Association
Principal Investigator: Opher Caspi, MD PhD Director, Integrative Medicine - Rabin Medical Center
More Information

Responsible Party: Opher Caspi, MD PhD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00726635     History of Changes
Other Study ID Numbers: 0014-08-RMC
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: July 2008

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female