Evaluation of Group CBT Programme With Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426335
Recruitment Status : Unknown
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : January 24, 2007
Last Update Posted : January 13, 2010
Information provided by:
Royal Marsden NHS Foundation Trust

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.

Condition or disease
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 Type : Observational
Estimated Enrollment : 78 participants
Time Perspective: Prospective
Official Title: An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
78 participants in total including 39 female RMH patients with primary breast cancer and are post adjuvant treatment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426335

Contact: Maggie Watson, Dr 020 8661 3009
Contact: Mary Burgess 020 7808 2777

United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Maggie Watson   
Contact: Mary Burgess   
Principal Investigator: Maggie Watson         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: Maggie Watson, Dr Royal Marsden NHS Foundation Trust Identifier: NCT00426335     History of Changes
Other Study ID Numbers: CCR2839
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases