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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Rabin Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Academic College of Tel Aviv-Jaffa
Israel Cancer Association
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00726635
First received: July 30, 2008
Last updated: February 15, 2009
Last verified: July 2008

July 30, 2008
February 15, 2009
August 2008
August 2009   (final data collection date for primary outcome measure)
psychological, physiological, immunological parameters [ Time Frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726635 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cancer of Cervix
  • Ovarian Cancer
  • Cancer of Endometrium
  • Behavioral: Cognitive intervention
    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 Name: Tailored cognitive intervention
  • Other: Control group
    A one hour conversation with a nurse
    Other Name: Control group
  • Other: psycho-physiological intervention
    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 Name: tailored psycho-physiological intervention
  • 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).
    Intervention: Other: Control group
  • Experimental: 2
    Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
    Intervention: Behavioral: Cognitive intervention
  • Experimental: 3
    Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
    Intervention: Other: psycho-physiological intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Opher Caspi, MD PhD 972-39377995 ocaspi@clalit.org.il
Israel
 
NCT00726635
0014-08-RMC
No
Opher Caspi, MD PhD, Rabin Medical Center
Rabin Medical Center
  • Academic College of Tel Aviv-Jaffa
  • Israel Cancer Association
Principal Investigator: Opher Caspi, MD PhD Director, Integrative Medicine - Rabin Medical Center
Rabin Medical Center
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP