Expressive Writing and Adjustment to Metastatic Breast Cancer

October 28, 2015 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

MSKCC clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.
2
control writing
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
Indiana University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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