The Effect of Cognitive Behavior Intervention on Psycholo... | NCT00279474

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

NCT00279474

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Jan 19, 2006Estimated

Enrollment

320

Phase

Not Applicable

Conditions

Cancer

Interventions

cognitive-behavior groups

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Jan 17, 2006

First Submission Date that Met QC Criteria

Jan 17, 2006

First Posted Date

Jan 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2006

Last Update Posted Date

Jan 19, 2006Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320

Name	Type	Description	Arm Group Labels	Other Names
cognitive-behavior groups	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in psychological distress, level of fatigue and sleep problems

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hebrew speaking

Exclusion Criteria:

psychiatric condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miri Cohen	Contact	972 523 688623		cohenm@research.haifa.ac.il
Georgeta Fried	Contact	972 4 853018

Overall Officials

Name	Affiliation	Role
Miri Cohen, PhD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam medical center, Oncology department	Recruiting	Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided