Back to resultsLife After Cancer: Behavioral Treatment Study to Improve Quality of Life
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive writing
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer, colon cancer, rectal cancer
Eligibility Criteria
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
Sites / Locations
- Temple University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Writing in a journal 15 minutes a day
Control Writing in a journal 15 minutes a day
Outcomes
Primary Outcome Measures
Depressive symptoms
self-report depressive symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473941
Brief Title
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
Official Title
Expressive Writing and Adjustment to Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, colon cancer, rectal cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Writing in a journal 15 minutes a day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Control Writing in a journal 15 minutes a day
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
Behavioral intervention using writing about cancer to improve quality of life outcomes
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
self-report depressive symptoms
Time Frame
2-Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Lepore, Ph.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracey A Revenson, Ph.D
Organizational Affiliation
Graduate College, City University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ccalliance.org/
Description
Colon Cancer Alliance
URL
http://www.cancerlinksusa.com/colorectal/index.asp
Description
Cancer Information Network
Learn more about this trial
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
We'll reach out to this number within 24 hrs