NCT00279474

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
Last Updated

January 19, 2006

Status Verified

October 1, 2005

First QC Date

January 17, 2006

Last Update Submit

January 17, 2006

Conditions

Cancer

Keywords

cancer patientsfamilycognitive behaviordistress

Outcome Measures

Primary Outcomes (1)

  • Reduction in psychological distress, level of fatigue and sleep problems

Interventions

cognitive-behavior groupsBEHAVIORAL

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hebrew speaking

You may not qualify if:

  • psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center, Oncology department

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Miri Cohen, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miri Cohen

CONTACT

972 523 688623cohenm@research.haifa.ac.il

Georgeta Fried

CONTACT

972 4 853018

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

July 1, 2004

Study Completion

December 1, 2005

Last Updated

January 19, 2006

Record last verified: 2005-10

Locations

IL(1)