Expressive Writing and Adjustment to Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Indiana University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00624156
First received: February 15, 2008
Last updated: January 25, 2012
Last verified: January 2012
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 98
Study Start Date: February 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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.
Other Names:
  • 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.
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
Other Names:
  • 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Indiana University
Investigators
Principal Investigator: Katherine DuHamel, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00624156     History of Changes
Other Study ID Numbers: 08-011
Study First Received: February 15, 2008
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014