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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00279474
First received: January 17, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hebrew speaking

Exclusion Criteria:

  • psychiatric condition
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00279474     History of Changes
Other Study ID Numbers: 1951CTIL
Study First Received: January 17, 2006
Last Updated: January 17, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on July 26, 2014