Effectiveness of an mHealth Colorectal Cancer Screening Intervention

NCT ID: NCT02088333

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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mCRC intervention

intervention arm

Group Type EXPERIMENTAL

mCRC intervention

Intervention Type BEHAVIORAL

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 education

tablet-based patient education about healthy lifestyles

Group Type PLACEBO_COMPARATOR

Healthy Lifestyles video

Intervention Type BEHAVIORAL

a brief video about healthy lifestyle habits displayed on a tablet device

Interventions

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mCRC intervention

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

Intervention Type BEHAVIORAL

Healthy Lifestyles video

a brief video about healthy lifestyle habits displayed on a tablet device

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of North Carolina, Charlotte

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David P Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Hillsdale Family Medicine

Advance, North Carolina, United States

Site Status

Foothills Family Medicine

Mount Airy, North Carolina, United States

Site Status

Wilkes Internal Medicine

Wilkesboro, North Carolina, United States

Site Status

Downtown Health Plaza

Winston-Salem, North Carolina, United States

Site Status

Peace Haven Family Medicine

Winston-Salem, North Carolina, United States

Site Status

Reynolda Family Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29532054 (View on PubMed)

Other Identifiers

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1R01CA178941

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU 59A13

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00023575

Identifier Type: -

Identifier Source: org_study_id

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