NCT02088333

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

March 10, 2014

Last Update Submit

February 16, 2022

Conditions

Colorectal Neoplasms

Keywords

colorectal cancer screeningcomputer-assisted instructionmHealthtext message

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (9)

  • CRC Screening Attitudes and Beliefs

    Day of enrollment

  • Intention to receive CRC screening

    Day of enrollment

  • Self-efficacy

    Day of enrollment

  • Ability to make a screening decision

    Day of enrollment

  • CRC screening discussions

    Up to 5 days

  • +4 more secondary outcomes

Study Arms (2)

mCRC intervention

EXPERIMENTAL

intervention arm

Behavioral: mCRC intervention

Healthy lifestyles education

PLACEBO COMPARATOR

tablet-based patient education about healthy lifestyles

Behavioral: Healthy Lifestyles video

Interventions

mCRC interventionBEHAVIORAL

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

mCRC intervention
Healthy Lifestyles videoBEHAVIORAL

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

Healthy lifestyles education

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hillsdale Family Medicine

Advance, North Carolina, 27006, United States

Location

Foothills Family Medicine

Mount Airy, North Carolina, 27030, United States

Location

Wilkes Internal Medicine

Wilkesboro, North Carolina, 28659, United States

Location

Downtown Health Plaza

Winston-Salem, North Carolina, 27101, United States

Location

Peace Haven Family Medicine

Winston-Salem, North Carolina, 27106, United States

Location

Reynolda Family Medicine

Winston-Salem, North Carolina, 27106, United States

Location

Related Publications (1)

  • 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.

    PMID: 29532054DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David P Miller, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 14, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations

US(6)