Colorectal NeoplasmsmCRCNCT02088333
Effectiveness of an mHealth Colorectal Cancer Screening Intervention
A study testing mCRC intervention and Healthy Lifestyles video in people with Colorectal Neoplasms, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- mCRC intervention and Healthy Lifestyles video
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2014to Oct 2016
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking patients aged 50 - 74 years
- Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
- Due for colorectal cancer screening
Who cannot join
- A personal history of CRC
- Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools
- Obvious physical or mental disability that would prevent participant from interacting with a tablet device.
- Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Hillsdale Family Medicine
Advance, North Carolina, 27006
Foothills Family Medicine
Mount Airy, North Carolina, 27030
Wilkes Internal Medicine
Wilkesboro, North Carolina, 28659
Downtown Health Plaza
Winston-Salem, North Carolina, 27101
Peace Haven Family Medicine
Winston-Salem, North Carolina, 27106
Reynolda Family Medicine
Winston-Salem, North Carolina, 27106
About this study
Official title: A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention
The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests, and electronic messaging with patients to promote screening. The investigators hypothesize that participants randomized to mCRC will be more likely to complete screening compared with those randomized to the control arm of the study. Additionally, the investigators hypothesize mCRC will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add little to the overall cost of screening.
- Conditions
- Colorectal Neoplasms
- Being tested
- mCRC intervention, Healthy Lifestyles video
- Keywords
- colorectal cancer screening, computer-assisted instruction, mHealth, text message
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCRC interventionBehavioural
a multilevel intervention consisting of tablet-based patient education about CRC screening, post-visit patient electronic messaging, and clinic protocols to facilitate ordering of screening tests
Healthy Lifestyles videoBehavioural
a brief video about healthy lifestyle habits displayed on a tablet device
| Study group | Role | What they receive |
|---|---|---|
| mCRC intervention | Experimental | intervention arm Receives: Behavioral: mCRC intervention |
| Healthy lifestyles education | Placebo comparator | tablet-based patient education about healthy lifestyles Receives: Behavioral: Healthy Lifestyles video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CRC Screening
Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.
Measured: 24 weeks
Secondary outcomes (9)
CRC Screening Attitudes and Beliefs
A survey scale measuring the participant's attitudes and beliefs about CRC screening
Measured: Day of enrollment
Intention to receive CRC screening
Participant's stated intention to receive CRC screening
Measured: Day of enrollment
Self-efficacy
Participant's belief that they are capable of completing CRC screening
Measured: Day of enrollment
Ability to make a screening decision
Measured: Day of enrollment
CRC screening discussions
Participants' self-report of whether they discussed CRC screening with a medical provider
Measured: Up to 5 days
Satisfaction with screening decision
Survey questions based on the Satisfaction with Decision Scale
Measured: Up to 5 days
CRC screening test order
Whether or not a CRC screening test was ordered for the participant
Measured: 24 weeks
Cost of the mCRC intervention
Additional cost of the mCRC intervention as captured by additional time and technology costs
Measured: 24 weeks
Usability of the mCRC system
Participant's rating of the usability of the mCRC system
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionOct 2016
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of North Carolina, Charlotte
- Responsible party
- Sponsor
- Investigators
- David P Miller, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088333
- Sponsor's protocol ID
- IRB00023575
- Other IDs
- 1R01CA178941, CCCWFU 59A13
- Acronym
- mCRC
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2014
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.
PubMed 29532054
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention
- ClinicalTrials.gov ID
- NCT02088333
- Acronym / sponsor ID
- mCRC / IRB00023575
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal cancer screening, computer-assisted instruction, mHealth, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of North Carolina, Charlotte
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Mar 2014 (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 this study is to determine whether a multilevel mHealth intervention (mCRC) can increase the percentage of patients who receive colorectal cancer screening. The mCRC intervention will include a tablet-based patient education program, clinic protocols to facilitate the ordering of CRC screening tests, and electronic messaging with patients to promote screening. The investigators hypothesize that participants randomized to mCRC will be more likely to complete screening compared with those randomized to the control arm of the study. Additionally, the investigators hypothesize mCRC will increase several intermediate outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add little to the overall cost of screening.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCRC intervention | Experimental | Behavioral: mCRC interventionintervention arm |
| Healthy lifestyles education | Placebo comparator | Behavioral: Healthy Lifestyles videotablet-based patient education about healthy lifestyles |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking patients aged 50 - 74 years
- Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit
- Due for colorectal cancer screening
Key exclusion criteria (4 listed)
- A personal history of CRC
- Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools
- Obvious physical or mental disability that would prevent participant from interacting with a tablet device.
- Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.
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 |
|---|---|---|
| mCRC interventiona multilevel intervention consisting of tablet-based patient education about CRC screening, post-visit patient electronic messaging, and clinic protocols to facilitate ordering of screening tests | Behavioural | mCRC intervention |
| Healthy Lifestyles videoa brief video about healthy lifestyle habits displayed on a tablet device | Behavioural | Healthy lifestyles education |
Primary outcome
Completion of CRC Screening
Time frame: 24 weeks
Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.
9 secondary outcomes
CRC Screening Attitudes and Beliefs
Time frame: Day of enrollment
Intention to receive CRC screening
Time frame: Day of enrollment
Self-efficacy
Time frame: Day of enrollment
Ability to make a screening decision
Time frame: Day of enrollment
CRC screening discussions
Time frame: Up to 5 days
Satisfaction with screening decision
Time frame: Up to 5 days
CRC screening test order
Time frame: 24 weeks
Cost of the mCRC intervention
Time frame: 24 weeks
Usability of the mCRC system
Time frame: Day of enrollment
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 17 Feb 2022.
- Derived from this study: PubMed 29532054Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.
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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 P Miller, MD, MS principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCRC intervention and Healthy Lifestyles video in people with Colorectal Neoplasms, run by Wake Forest University Health Sciences at 6 sites 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 4 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Completion of CRC Screening (time frame: 24 weeks). 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 NCT02088333, 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 17 Feb 2022.