The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Petah Tikva, Israel, 49100
- Recruiting
- Rabin Medical Center
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Contact:
- Opher Caspi, MD PhD
- Phone Number: 972-3937795
- Email: ocaspi@clalit.org.il
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Contact:
- Mira Livingstone, B.A
- Phone Number: 972-542562083
- Email: mira.livingstone@gmail.com
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Principal Investigator:
- Opher Caspi, MD PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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A one hour conversation with a nurse
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Experimental: 2
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
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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 Names:
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Experimental: 3
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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psychological, physiological, immunological parameters
Time Frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
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A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Opher Caspi, MD PhD, Director, Integrative Medicine - Rabin Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0014-08-RMC
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