Expressive Writing and Adjustment to Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Expressive Writing and Adjustment to Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624156
• Other study ID #: 08-011
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: October 28, 2015
• Start date: February 2008
• Est. completion date: January 2012

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

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.
• 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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Indiana University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		conclusion of the study	No
Secondary	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.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center