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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00726635
• Other study ID #: 0014-08-RMC
• Status: Recruiting
• Phase: Phase 3
• First received: July 30, 2008
• Last updated: February 15, 2009
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2008
• Source: Rabin Medical Center
• Contact: Opher Caspi, MD PhD
• Phone: 972-39377995
• Email: ocaspi[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer of Cervix
• Cancer of Endometrium
• Ovarian Cancer
• Uterine Cervical Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Rabin Medical center	Petah Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	Academic College of Tel Aviv-Jaffa, Israel Cancer Association

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychological, physiological, immunological parameters		A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery	No