Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-03 @ 3:54 PM
Study NCT ID:
NCT00624156
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expressive Writing and Adjustment to Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the potential utility of expressive writing for enhancing existential well-being (i.e., increasing a sense of meaning and peace and reducing demoralization) among women with metastatic breast cancer.', 'timeFrame': 'conclusion of the study'}], 'secondaryOutcomes': [{'measure': 'Determine the potential utility of expressive writing for reducing distress (i.e., depressive symptoms, anxiety, cancer-specific and general distress) among women with metastatic breast cancer.', 'timeFrame': 'conclusion of the study'}]}, 'conditionsModule': {'keywords': ['Breast Cancer'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21678181', 'type': 'DERIVED', 'citation': 'Mosher CE, Duhamel KN, Lam J, Dickler M, Li Y, Massie MJ, Norton L. Randomised trial of expressive writing for distressed metastatic breast cancer patients. Psychol Health. 2012;27(1):88-100. doi: 10.1080/08870446.2010.551212. Epub 2011 Jul 8.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'We are doing this study to see if writing about life experiences helps women adjust to breast cancer that has spread. We will compare two groups. One group will write about their breast cancer experience. The other will write about their daily activities. What we learn from this study may help us to find new ways to help women cope with breast cancer that has spread.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'MSKCC clinics', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with Stage IV breast cancer\n* Receiving cancer care at Memorial Sloan-Kettering Cancer Center\n* At least 18 years of age\n* Can speak, read, and write in English\n* In the judgment of consenting professionals able to provide informed consent\n* Score of 4 or higher on the distress thermometer (established cutoff score for probable distress; see Jacobsen et al., 2005)\n\nExclusion Criteria:\n\n* Significant psychiatric or cognitive impairment (dementia/delirium, retardation, psychosis) that in the judgment of the investigators will preclude providing informed consent and participating in the intervention\n* Currently engaging in expressive writing (e.g., journal writing that involves expressing one's feelings) on a daily basis\n* Currently participating in intervention trials with similar endpoints • Male"}, 'identificationModule': {'nctId': 'NCT00624156', 'briefTitle': 'Expressive Writing and Adjustment to Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Expressive Writing and Adjustment to Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '08-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'emotional disclosure writing intervention', 'interventionNames': ['Behavioral: Writing Intervention']}, {'label': '2', 'description': 'control writing', 'interventionNames': ['Behavioral: Writing Intervention']}], 'interventions': [{'name': 'Writing Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Over four sessions, I want you to write about your experience with cancer. In your writing, I', 'want you to really let go and explore your very deepest emotions and thoughts. It is critical that you', 'delve deeply.'], 'description': 'Participants in the emotional disclosure condition will be instructed to write continuously for 20 minutes about their deepest thoughts and feelings regarding their cancer experience.', 'armGroupLabels': ['1']}, {'name': 'Writing Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Over four sessions, I want you to write about how you use your time. I am interested in', 'everything you do during the course of a day. I realize that you experience many emotions, but in', 'your writing I want you to focus only on the facts, not on your emotions.'], 'description': 'Participants assigned to the control condition will be instructed to describe in a detailed, nonemotional manner their daily activities. The 20-minute writing task will be introduced as a time management intervention', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Katherine DuHamel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}