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Evaluation of Group CBT Programme With Breast Cancer Patients

This study is not yet open for participant recruitment.
Verified by Royal Marsden NHS Foundation Trust, January 2006

Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00426335
  Purpose

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.


Condition Phase
Breast Cancer
Phase 0

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Psychosocial, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:   An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.

Further study details as provided by Royal Marsden NHS Foundation Trust:

Study Start Date:   January 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female

Criteria

Inclusion Criteria:

  • Female
  • Primary breast cancer
  • post adjuvant treatment

Exclusion Criteria:

  • Women with metastatic disease
  • Severe cognitive impairment (will not be able to obtain consent or participant in group intervention)
  • Inability to complete a questionnaire
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426335

Contacts
Contact: Maggie Watson, Dr     020 8661 3009     maggie.watson@rmh.nhs.uk    
Contact: Mary Burgess     020 7808 2777     mary.burgess@rmh.nhs.uk    

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust

Investigators
Principal Investigator:     Maggie Watson, Dr     The Royal Marsden NHS Foundation Trust    
  More Information


Study ID Numbers:   CCR2839
First Received:   January 23, 2007
Last Updated:   January 23, 2007
ClinicalTrials.gov Identifier:   NCT00426335
Health Authority:   United Kingdom: National Health Service

Keywords provided by Royal Marsden NHS Foundation Trust:
breast  
cancer  
cognitive behaviour therapy  
psychological  

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 23, 2008




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