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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00279474
First Posted: January 19, 2006
Last Update Posted: January 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
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 Intervention
Cancer Behavioral: cognitive-behavior groups

Study Type: Interventional
Study Design: 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

Further study details as provided by Rambam Health Care Campus:

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

Estimated Enrollment: 320
Study Start Date: July 2004
Estimated Study Completion Date: December 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Hebrew speaking

Exclusion Criteria:

  • psychiatric condition
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00279474     History of Changes
Other Study ID Numbers: 1951CTIL
First Submitted: January 17, 2006
First Posted: January 19, 2006
Last Update Posted: January 19, 2006
Last Verified: October 2005

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