Viewing Study NCT00426335


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Study NCT ID: NCT00426335
Status: UNKNOWN
Last Update Posted: 2010-01-13
First Post: 2007-01-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Evaluation of Group CBT Programme With Breast Cancer Patients
Sponsor: Royal Marsden NHS Foundation Trust
Organization:

Study Overview

Official Title: An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.
Status: UNKNOWN
Status Verified Date: 2010-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to examine whether a group CBT intervention is effective in reducing psychological distress in women with primary breast cancer.
Detailed Description: The diagnosis and treatment of cancer is associated with high levels of psychological distress, which can be long-term in duration. The end of adjuvant therapy can be a time which patients find anxiety provoking; as concerns of recurrence and how to return to life after treatment often arise at this juncture.

Cognitive behaviour therapy has demonstrated efficacy in reducing anxiety and depression in people with cancer on a 1:1 basis. The CBT model has been shown to be significantly more beneficial than supportive counselling. Therapy delivered in groups is considered desirable because of its cost effectiveness, and its potential to confer additional benefits in terms of peer support, reduced isolation and modelling of adaptive strategies by other group members.

No studies have looked at the changes in participants health beliefs and beliefs about their ability to copy (self-efficacy) with stress and tolerance of uncertainty following group CBT and the relationship with psychological distress.

The aim of this study is to evaluate a GCBT programme intervention against a waiting list control and to examine its effects on health beliefs, self-efficacy, coping, tolerance of uncertainty and psychological distress in women with early diagnosed breast cancer.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: