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

Primary Purpose

Cancer of Cervix, Ovarian Cancer, Cancer of Endometrium

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Cognitive intervention
Control group
psycho-physiological intervention
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Cervix

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin Medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).

Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)

Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)

Outcomes

Primary Outcome Measures

psychological, physiological, immunological parameters

Secondary Outcome Measures

Full Information

First Posted
July 30, 2008
Last Updated
February 15, 2009
Sponsor
Rabin Medical Center
Collaborators
Academic College of Tel Aviv-Jaffa, Israel Cancer Association
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1. Study Identification

Unique Protocol Identification Number
NCT00726635
Brief Title
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

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center
Collaborators
Academic College of Tel Aviv-Jaffa, Israel Cancer Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Cervix, Ovarian Cancer, Cancer of Endometrium

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
Arm Title
2
Arm Type
Experimental
Arm Description
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
Arm Title
3
Arm Type
Experimental
Arm Description
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive intervention
Other Intervention Name(s)
Tailored cognitive intervention
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
A one hour conversation with a nurse
Intervention Type
Other
Intervention Name(s)
psycho-physiological intervention
Other Intervention Name(s)
tailored psycho-physiological intervention
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
Primary Outcome Measure Information:
Title
psychological, physiological, immunological parameters
Time Frame
A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Opher Caspi, MD PhD
Phone
972-39377995
Email
ocaspi@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Opher Caspi, MD PhD
Organizational Affiliation
Director, Integrative Medicine - Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Opher Caspi, MD PhD
Phone
972-3937795
Email
ocaspi@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Mira Livingstone, B.A
Phone
972-542562083
Email
mira.livingstone@gmail.com
First Name & Middle Initial & Last Name & Degree
Opher Caspi, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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