Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 9:13 AM
Study NCT ID:
NCT00426335
Status:
UNKNOWN
Last Update Posted:
2010-01-13
First Post:
2007-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Group CBT Programme With Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2007-01-23', 'studyFirstSubmitQcDate': '2007-01-23', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['breast', 'cancer', 'cognitive behaviour therapy', 'psychological'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCognitive 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.\n\nNo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '78 participants in total including 39 female RMH patients with primary breast cancer and are post adjuvant treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Primary breast cancer\n* post adjuvant treatment\n\nExclusion Criteria:\n\n* Women with metastatic disease\n* Severe cognitive impairment (will not be able to obtain consent or participant in group intervention)\n* Inability to complete a questionnaire'}, 'identificationModule': {'nctId': 'NCT00426335', 'briefTitle': 'Evaluation of Group CBT Programme With Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.', 'orgStudyIdInfo': {'id': 'CCR2839'}}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Maggie Watson', 'role': 'CONTACT', 'email': 'maggie.watson@rmh.nhs.uk'}, {'name': 'Mary Burgess', 'role': 'CONTACT', 'email': 'mary.burgess@rmh.nhs.uk'}, {'name': 'Maggie Watson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Maggie Watson, Dr', 'role': 'CONTACT', 'email': 'maggie.watson@rmh.nhs.uk', 'phone': '020 8661 3009'}, {'name': 'Mary Burgess', 'role': 'CONTACT', 'email': 'mary.burgess@rmh.nhs.uk', 'phone': '020 7808 2777'}], 'overallOfficials': [{'name': 'Maggie Watson, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}}}}