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Trial Title:
The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
NCT ID:
NCT00726635
Condition:
Cancer of Cervix
Ovarian Cancer
Cancer of Endometrium
Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive intervention
Description:
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.
Arm group label:
2
Other name:
Tailored cognitive intervention
Intervention type:
Other
Intervention name:
Control group
Description:
A one hour conversation with a nurse
Arm group label:
1
Intervention type:
Other
Intervention name:
psycho-physiological intervention
Description:
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
Arm group label:
3
Other name:
tailored psycho-physiological intervention
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rabin Medical center
Address:
City:
Petah Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Opher Caspi, MD PhD
Phone:
972-3937795
Email:
ocaspi@clalit.org.il
Contact backup:
Last name:
Mira Livingstone, B.A
Phone:
972-542562083
Email:
mira.livingstone@gmail.com
Investigator:
Last name:
Opher Caspi, MD PhD
Email:
Principal Investigator
Start date:
August 2008
Completion date:
August 2009
Lead sponsor:
Agency:
Rabin Medical Center
Agency class:
Other
Collaborator:
Agency:
Academic College of Tel Aviv-Jaffa
Agency class:
Other
Collaborator:
Agency:
Israel Cancer Association
Agency class:
Other
Source:
Rabin Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00726635
