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

Sponsors

Lead Sponsor: Rabin Medical Center

Collaborator: Academic College of Tel Aviv-Jaffa
Israel Cancer Association

Source Rabin Medical Center
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.

Overall Status Unknown status
Start Date August 2008
Completion Date August 2009
Primary Completion Date August 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
psychological, physiological, immunological parameters A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
Enrollment 60
Condition
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

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

Overall Official
Last Name Role Affiliation
Opher Caspi, MD PhD Principal Investigator Director, Integrative Medicine - Rabin Medical Center
Overall Contact

Last Name: Opher Caspi, MD PhD

Phone: 972-39377995

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Rabin Medical center Opher Caspi, MD PhD 972-3937795 [email protected] Opher Caspi, MD PhD Principal Investigator
Location Countries

Israel

Verification Date

July 2008

Responsible Party

Name Title: Opher Caspi, MD PhD

Organization: Rabin Medical Center

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Active Comparator

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).

Label: 2

Type: Experimental

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

Label: 3

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov