Evaluation of Group CBT Programme With Breast Cancer Patients

NCT ID: NCT00426335

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

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Maggie Watson, Dr

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Maggie Watson, Dr

Role: CONTACT

020 8661 3009

Mary Burgess

Role: CONTACT

020 7808 2777

Facility Contacts

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Maggie Watson

Role: primary

Mary Burgess

Role: backup

Other Identifiers

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CCR2839

Identifier Type: -

Identifier Source: org_study_id

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