Expressive Writing and Adjustment to Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00624156

Purpose

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.

Condition	Intervention
Metastatic Breast Cancer	Behavioral: Writing Intervention

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Expressive Writing and Adjustment to Metastatic Breast Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	98
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 emotional disclosure writing intervention	Behavioral: Writing Intervention 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.
2 control writing	Behavioral: Writing Intervention 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

MSKCC clinics

Criteria

Inclusion Criteria:

Women with Stage IV breast cancer
Receiving cancer care at Memorial Sloan-Kettering Cancer Center
At least 18 years of age
Can speak, read, and write in English
In the judgment of consenting professionals able to provide informed consent
Score of 4 or higher on the distress thermometer (established cutoff score for probable distress; see Jacobsen et al., 2005)

Exclusion Criteria:

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
Currently engaging in expressive writing (e.g., journal writing that involves expressing one's feelings) on a daily basis
Currently participating in intervention trials with similar endpoints • Male

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624156

Contacts

Contact: Katherine DuHamamel, PhD		duhamelk@mskcc.org
Contact: Mary Jane Massie, MD		massiem@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Katherine DuHamel, PhD duhamelk@mskcc.org
Contact: Mary Jane Massie, MD massiem@mskcc.org
Principal Investigator: Katherine DuHamel, PhD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Katherine DuHamel, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Katherine DuHamel, Ph.D )
Study ID Numbers:	08-011
Study First Received:	February 15, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00624156
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on February 06, 2009