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The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Conditions
Cancer of Cervix - Ovarian Cancer - Cancer of Endometrium
Conditions: official terms
Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Cognitive intervention
Type: Behavioral
Name: Control group
Type: Other
Name: psycho-physiological intervention
Type: Other
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
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
- 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
Location
Rabin Medical center
Petah Tikva, Israel
Status: Recruiting
Contact: Opher Caspi, MD PhD - 972-3937795 - ocaspi@clalit.org.il
Start Date
August 2008
Completion Date
August 2009
Sponsors
Rabin Medical Center
Source
Rabin Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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