Colorectal CancerNCT00459030
Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening
A study testing educational intervention via internet, educational intervention mailed and No additional educational intervention in people with Colorectal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- educational intervention via internet, educational intervention mailed and No additional educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2012
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- At average risk for colorectal cancer (CRC) as defined by the following criteria:
- Asymptomatic without a personal history of colorectal polyps or cancer
- No inflammatory bowel disease
- No family history of familial adenomatous polyposis or hereditary nonpolyposis CRC
- No CRC in more than one first-degree relative
- Nonadherent with standard CRC screening recommendations at the time of index OB/Gyn appointment
PATIENT CHARACTERISTICS:
- Email accessible at home and/or work
- Able to communicate with ease in English
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Two Delivery Channels to Improve CRC Screening
RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening.
PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.
Read the detailed description
OBJECTIVES:
- Compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (CRC) screening rates, in average-risk women attending a routine OB/Gyn visit.
- Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
- Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
- Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 screening arms.
- Arm I: Participants are contacted by simple electronic communication methods by an email message linked to a personalized website.
- Arm II: Participants are contacted by traditional print communication methods.
- Arm III: Participants are observed (usual care). Participants in arms I and II are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style.
PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- educational intervention via internet, educational intervention mailed, No additional educational intervention
- Keywords
- 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.
educational intervention via internetOther
additional cancer screening information via password protected internet site
educational intervention mailedOther
No additional educational interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Print Communication | Experimental | Cancer screening educational information mailed to patient's home one time after signing consent. Receives: Other: educational intervention mailed |
| Electronic communication | Experimental | Cancer screening educational information delivered via a password protected internet site. Receives: Other: educational intervention via internet |
| No Health Communication | Active comparator | No additional cancer screening education information sent to patient. Receives: Other: No additional educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates
Measured: End of study
Secondary outcomes (2)
Moderating role of attentional style and background variables on the impact of the interventions
Measured: End of Study
Mediating effect of potential cognitive-affective factors related to CRC screening
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startOct 2005
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Weinberg, MD, MSC, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459030
- Sponsor's protocol ID
- FCCC-05016
- Other IDs
- CDR0000538413, IRB05-016, R01CA102695
- Status last verified
- Aug 2013
- First submitted
- 9 Apr 2007
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Weinberg DS, Keenan E, Ruth K, Devarajan K, Rodoletz M, Bieber EJ. A randomized comparison of print and web communication on colorectal cancer screening. JAMA Intern Med. 2013 Jan 28;173(2):122-9. doi: 10.1001/2013.jamainternmed.1017.
PubMed 23128366
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Delivery Channels to Improve CRC Screening
- ClinicalTrials.gov ID
- NCT00459030
- Acronym / sponsor ID
- FCCC-05016
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 904 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Apr 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.
RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening.
PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.
Detailed description
OBJECTIVES:
- Compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (CRC) screening rates, in average-risk women attending a routine OB/Gyn visit.
- Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
- Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
- Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 screening arms.
- Arm I: Participants are contacted by simple electronic communication methods by an email message linked to a personalized website.
- Arm II: Participants are contacted by traditional print communication methods.
- Arm III: Participants are observed (usual care). Participants in arms I and II are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style.
PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Print Communication | Experimental | Other: educational intervention mailedCancer screening educational information mailed to patient's home one time after signing consent. |
| Electronic communication | Experimental | Other: educational intervention via internetCancer screening educational information delivered via a password protected internet site. |
| No Health Communication | Active comparator | Other: No additional educational interventionNo additional cancer screening education information sent to patient. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| educational intervention via internetadditional cancer screening information via password protected internet site | Other | Electronic communication |
| educational intervention mailed | Other | Print Communication |
| No additional educational intervention | Other | No Health Communication |
Primary outcome
Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates
Time frame: End of study
2 secondary outcomes
Moderating role of attentional style and background variables on the impact of the interventions
Time frame: End of Study
Mediating effect of potential cognitive-affective factors related to CRC screening
Time frame: End of study
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 19 Aug 2013.
- Results publication: PubMed 23128366Weinberg DS, Keenan E, Ruth K, Devarajan K, Rodoletz M, Bieber EJ. A randomized comparison of print and web communication on colorectal cancer screening. JAMA Intern Med. 2013 Jan 28;173(2):122-9. doi: 10.1001/2013.jamainternmed.1017.
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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.
David Weinberg, MD, MSC study chair
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention via internet, educational intervention mailed and No additional educational intervention in people with Colorectal Cancer, run by Fox Chase Cancer Center 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?
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 19 Aug 2013. 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. 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?
Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459030, which also lists 1 linked publication.
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 19 Aug 2013.