Clinical trial NCT00726635: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer of Cervix
Ovarian Cancer
Cancer of Endometrium
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Academic College of Tel Aviv-Jaffa
name: Israel Cancer Association
First posted: 2008-08-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: psychological, physiological, immunological parameters
timeFrame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical center
Study officials:
affiliation: Director, Integrative Medicine - Rabin Medical Center
name: Opher Caspi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: