Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-02 @ 3:48 PM
Study NCT ID:
NCT00094133
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2004-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis in Treating Hot Flashes in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D058922', 'term': 'Inflammatory Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2004-10-14', 'studyFirstSubmitQcDate': '2004-10-14', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot flash control by Hot Flash Daily Diary in week 6'}]}, 'conditionsModule': {'keywords': ['cancer survivor', 'stage IA breast cancer', 'stage IB breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer', 'breast cancer in situ', 'inflammatory breast cancer', 'hot flashes'], 'conditions': ['Breast Cancer', 'Cancer Survivor', 'Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '18809612', 'type': 'RESULT', 'citation': 'Elkins G, Marcus J, Stearns V, Perfect M, Rajab MH, Ruud C, Palamara L, Keith T. Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008 Nov 1;26(31):5022-6. doi: 10.1200/JCO.2008.16.6389. Epub 2008 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Hypnosis may be effective in decreasing hot flashes in breast cancer survivors.\n\nPURPOSE: This randomized clinical trial is studying how well hypnosis works in treating hot flashes in breast cancer survivors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of hypnosis in controlling hot flashes in women who are breast cancer survivors.\n* Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention.\n\nOUTLINE: This is a randomized, controlled study. Patients are stratified according to age, gender, race, and educational background. All patients complete a Hot Flash Daily Diary to record frequency and severity of hot flashes for 1 week. Patients are then randomized to 1 of 2 treatment arms.\n\n* Arm I (hypnotherapy): Patients undergo hypnotherapy once a week for 5 weeks. Patients complete the Hot Flash-Related Daily Interference Scale, the Hospital Depression and Anxiety Sub-scale, the CES Depression Scale, and the MOS-Sleep and Sexual Function Scales in week 5 after the last hypnotherapy intervention. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.\n* Arm II (control): Patients receive no contact for 4 weeks. Patients complete the questionnaires as in arm I in week 5. Patients also complete another Hot Flash Daily Diary for 1 week in week 6 and are administered the Stanford Hypnotic Clinical Scale in week 7.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* History of primary breast cancer\n\n * No evidence of detectable disease\n* At least 14 hot flashes per week for ≥ 1 month by self-reporting\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Life expectancy \\> 6 months\n* Menopausal status not specified\n* Outpatient status\n* No medical or psychiatric condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\n* Concurrent antihormonal agents for breast cancer (e.g., tamoxifen or raloxifene) allowed provided the patient has been on them for ≥ 1 month\n* No other concurrent hormonal therapy\n* No other putative therapies for hot flashes ≥ 1 month prior to study entry\n\n * Concurrent vitamin E allowed\n* No other concurrent treatment for hot flashes\n* No concurrent cytotoxic chemotherapy\n* Not concurrently using hypnosis for any reason'}, 'identificationModule': {'nctId': 'NCT00094133', 'briefTitle': 'Hypnosis in Treating Hot Flashes in Breast Cancer Survivors', 'nctIdAliases': ['NCT00324337'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Hypnosis for Hot Flashes in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'CDR0000481365'}, 'secondaryIdInfos': [{'id': 'S-WHITE-8165'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'hot flashes attenuation', 'type': 'PROCEDURE'}, {'name': 'hypnotherapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office - Scott and White Cancer Institute', 'role': 'CONTACT', 'phone': '800-882-4366'}], 'facility': 'Scott and White Cancer Institute', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Gary Elkins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scott and White Hospital & Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}