- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473941
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
July 29, 2022 updated by: Temple University
Expressive Writing and Adjustment to Colorectal Cancer
The purpose of the study is to find new ways to improve the quality of life of people who have been treated for colon or rectal cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Individuals who take part in the study can expect:
Two Interviews:
- To be interviewed by our research staff over the phone. The interviews will include questions about your current quality of life and health.
Brief Writing in a Journal:
- To write for 15 minutes twice a week for two weeks about aspects of your life.
Study Type
Interventional
Enrollment (Actual)
193
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Temple University
-
-
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
All
Description
Inclusion Criteria:
- Treated for stage I, II or III colon or rectal cancer in the past 5 years
- Completed surgical treatment
- Must be able to read and write in English
Exclusion Criteria:
- History of other cancers, with the exception of non-melanoma skin cancer
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Writing in a journal 15 minutes a day
|
Behavioral intervention using writing about cancer to improve quality of life outcomes
|
Placebo Comparator: 2
Control Writing in a journal 15 minutes a day
|
Behavioral intervention using writing about cancer to improve quality of life outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms
Time Frame: 2-Weeks
|
self-report depressive symptoms
|
2-Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Lepore, Ph.D., Temple University
- Principal Investigator: Tracey A Revenson, Ph.D, Graduate College, City University of New York
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.
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
September 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 16, 2007
Study Record Updates
Last Update Posted (Actual)
August 2, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21CA107428-01A2 (U.S. NIH Grant/Contract)
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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