NCT00624156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

February 15, 2008

Last Update Submit

October 28, 2015

Conditions

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

1

emotional disclosure writing intervention

Behavioral: Writing Intervention

2

control writing

Behavioral: Writing Intervention

Interventions

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.

Also known as: 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.
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MSKCC clinics

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Mosher CE, Duhamel KN, Lam J, Dickler M, Li Y, Massie MJ, Norton L. Randomised trial of expressive writing for distressed metastatic breast cancer patients. Psychol Health. 2012;27(1):88-100. doi: 10.1080/08870446.2010.551212. Epub 2011 Jul 8.

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Katherine DuHamel, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations