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Colorectal CancerNCT00599378

Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

A study testing Implementation Intentions-based telephone counseling in people with Colorectal Cancer, run by Kimberly Engelman, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Implementation Intentions-based telephone counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
373 participants
Where
1 siteUnited States
Study dates
Sep 2007to Jun 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 50 years of age or older
  • at average risk for colorectal cancer
  • not up to date with colorectal cancer screening

Who cannot join

  • Younger than 50 years of age
  • at high risk for colorectal cancer
  • up to date with colorectal cancer screening

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.

Read the detailed description

Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population. A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details). The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment. Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls. Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts). Physicians will receive informational fax sheets summarizing all participant phone calls. A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered. The primary outcome will be CRC screening adherence at 120 days. Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients.

Being tested
Implementation Intentions-based telephone counseling
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation Intentions-based telephone counselingBehavioural

    Implementation Intentions-based telephone counseling

Study groups in NCT00599378
Study groupRoleWhat they receive
1ExperimentalImplementation Intentions-based telephone counseling. Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.
Receives: Behavioral: Implementation Intentions-based telephone counseling
2No interventionHealthy Living information on Physical Activity and Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Follow up survey to assess participant compliance with CRC screening. For those non compliant participants, randomized to either Control group or CPI2 group - active intervention with implementation intentions-based communication concepts

    Measured: 60 days

Secondary outcomes (1)
  1. 120 day followup survey to assess perceived barriers and screening decisional stage

    Measured: 120 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionDec 2011
  4. Study completionJun 2012

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599378
Sponsor's protocol ID
11018
Other IDs
1R01CA121016-01A2
Status last verified
Sep 2013
First submitted
31 Dec 2007
Last updated
10 Sep 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Implementation Intentions-based telephone counseling in people with Colorectal Cancer, run by Kimberly Engelman, PhD 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 3 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 10 Sep 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?

Follow up survey to assess participant compliance with CRC screening. For those non compliant participants, randomized to either Control group or CPI2 group - active intervention with implementation intentions-based communication concepts (time frame: 60 days). 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 10 Sep 2013.

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