Evaluation of Group CBT Programme With Breast Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00426335
First received: January 23, 2007
Last updated: January 12, 2010
Last verified: January 2010
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.

Resource links provided by NLM:


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

Estimated Enrollment: 78
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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Maggie Watson       maggie.watson@rmh.nhs.uk   
Contact: Mary Burgess       mary.burgess@rmh.nhs.uk   
Principal Investigator: Maggie Watson         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Maggie Watson, Dr The Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426335     History of Changes
Other Study ID Numbers: CCR2839
Study First Received: January 23, 2007
Last Updated: January 12, 2010
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on September 18, 2014