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The Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members

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ClinicalTrials.gov Identifier: NCT00279474
Recruitment Status : Unknown
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : January 19, 2006
Last Update Posted : January 19, 2006
Sponsor:
Information provided by:
Rambam Health Care Campus

Brief Summary:
The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: cognitive-behavior groups Not Applicable

Detailed Description:
The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls (randomized control study). Brief Symptom Inventory,Fatigue inventory, Mini Sleep Questionnaire and repression-sensitization questionnaire will be answered by the participants pre-, post-intervention and after four months.

Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members
Study Start Date : July 2004
Study Completion Date : December 2005



Primary Outcome Measures :
  1. Reduction in psychological distress, level of fatigue and sleep problems


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hebrew speaking

Exclusion Criteria:

  • psychiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279474


Contacts
Contact: Miri Cohen 972 523 688623 cohenm@research.haifa.ac.il
Contact: Georgeta Fried 972 4 853018

Locations
Israel
Rambam medical center, Oncology department Recruiting
Haifa, Israel
Contact: Miri Cohen, PhD    972 52 3688623    cohenm@research.haifa.ac.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Miri Cohen, PhD Rambam Health Care Campus

ClinicalTrials.gov Identifier: NCT00279474     History of Changes
Other Study ID Numbers: 1951CTIL
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: January 19, 2006
Last Verified: October 2005

Keywords provided by Rambam Health Care Campus:
cancer patients
family
cognitive behavior
distress