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Expressive Writing and Adjustment to Metastatic Breast Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00624156
Collaborator
National Cancer Institute (NCI) (NIH), Indiana University (Other)
98
Enrollment
1
Location
47
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Writing Intervention
  • Behavioral: Writing Intervention

Study Design

Study Type:
Observational
Actual Enrollment :
98 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Expressive Writing and Adjustment to Metastatic Breast Cancer
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • National Cancer Institute (NCI)
    • Indiana University

    Investigators

    • Principal Investigator: Katherine DuHamel, PhD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00624156
    Other Study ID Numbers:
    • 08-011
    First Posted:
    Feb 26, 2008
    Last Update Posted:
    Oct 30, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 30, 2015