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Trial Title:
Evaluation of Group CBT Programme With Breast Cancer Patients
NCT ID:
NCT00426335
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast
cancer
cognitive behaviour therapy
psychological
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
78 participants in total including 39 female RMH patients with primary breast cancer and
are post adjuvant treatment.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Marsden NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Maggie Watson
Email:
maggie.watson@rmh.nhs.uk
Contact backup:
Last name:
Mary Burgess
Email:
mary.burgess@rmh.nhs.uk
Investigator:
Last name:
Maggie Watson
Email:
Principal Investigator
Start date:
January 2007
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00426335
