Colorectal CancerNCT00473941
Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
A study testing Expressive writing in people with Colorectal Cancer, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of other cancers, with the exception of non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Expressive writing
- Keywords
- colorectal cancer, colon cancer, rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
Behavioral intervention using writing about cancer to improve quality of life outcomes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Writing in a journal 15 minutes a day Receives: Behavioral: Expressive writing |
| 2 | Placebo comparator | Control Writing in a journal 15 minutes a day Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
self-report depressive symptoms
Measured: 2-Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startSep 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Lepore, Ph.D., Principal investigator, Temple UniversityTracey A Revenson, Ph.D, Principal investigator, Graduate College, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473941
- Sponsor's protocol ID
- 1R21CA107428-01A2
- Status last verified
- Jul 2022
- First submitted
- 15 May 2007
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing and Adjustment to Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00473941
- Acronym / sponsor ID
- 1R21CA107428-01A2
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Expressive writingWriting in a journal 15 minutes a day |
| 2 | Placebo comparator | Behavioral: Expressive writingControl Writing in a journal 15 minutes a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- History of other cancers, with the exception of non-melanoma skin cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingBehavioral intervention using writing about cancer to improve quality of life outcomes | Behavioural | 1, 2 |
Primary outcome
Depressive symptoms
Time frame: 2-Weeks
self-report depressive symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Colon Cancer AllianceLink provided by the sponsor.
- Cancer Information NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lepore, Ph.D. principal investigator
Temple University
Tracey A Revenson, Ph.D principal investigator
Graduate College, City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Colorectal Cancer, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 2-Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.