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Effectiveness of an mHealth Colorectal Cancer Screening Intervention (mCRC)

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mCRC intervention
Healthy Lifestyles video
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Neoplasms focused on measuring colorectal cancer screening, computer-assisted instruction, mHealth, text message

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hillsdale Family Medicine
  • Foothills Family Medicine
  • Wilkes Internal Medicine
  • Downtown Health Plaza
  • Peace Haven Family Medicine
  • Reynolda Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mCRC intervention

Healthy lifestyles education

Arm Description

intervention arm

tablet-based patient education about healthy lifestyles

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CRC Screening Attitudes and Beliefs
A survey scale measuring the participant's attitudes and beliefs about CRC screening
Intention to receive CRC screening
Participant's stated intention to receive CRC screening
Self-efficacy
Participant's belief that they are capable of completing CRC screening
Ability to make a screening decision
CRC screening discussions
Participants' self-report of whether they discussed CRC screening with a medical provider
Satisfaction with screening decision
Survey questions based on the Satisfaction with Decision Scale
CRC screening test order
Whether or not a CRC screening test was ordered for the participant
Cost of the mCRC intervention
Additional cost of the mCRC intervention as captured by additional time and technology costs
Usability of the mCRC system
Participant's rating of the usability of the mCRC system

Full Information

First Posted
March 10, 2014
Last Updated
February 16, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT02088333
Brief Title
Effectiveness of an mHealth Colorectal Cancer Screening Intervention
Acronym
mCRC
Official Title
A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), University of North Carolina, Charlotte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colorectal cancer screening, computer-assisted instruction, mHealth, text message

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mCRC intervention
Arm Type
Experimental
Arm Description
intervention arm
Arm Title
Healthy lifestyles education
Arm Type
Placebo Comparator
Arm Description
tablet-based patient education about healthy lifestyles
Intervention Type
Behavioral
Intervention Name(s)
mCRC intervention
Intervention Description
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
Intervention Name(s)
Healthy Lifestyles video
Intervention Description
a brief video about healthy lifestyle habits displayed on a tablet device
Primary Outcome Measure Information:
Title
Completion of CRC Screening
Description
Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
CRC Screening Attitudes and Beliefs
Description
A survey scale measuring the participant's attitudes and beliefs about CRC screening
Time Frame
Day of enrollment
Title
Intention to receive CRC screening
Description
Participant's stated intention to receive CRC screening
Time Frame
Day of enrollment
Title
Self-efficacy
Description
Participant's belief that they are capable of completing CRC screening
Time Frame
Day of enrollment
Title
Ability to make a screening decision
Time Frame
Day of enrollment
Title
CRC screening discussions
Description
Participants' self-report of whether they discussed CRC screening with a medical provider
Time Frame
Up to 5 days
Title
Satisfaction with screening decision
Description
Survey questions based on the Satisfaction with Decision Scale
Time Frame
Up to 5 days
Title
CRC screening test order
Description
Whether or not a CRC screening test was ordered for the participant
Time Frame
24 weeks
Title
Cost of the mCRC intervention
Description
Additional cost of the mCRC intervention as captured by additional time and technology costs
Time Frame
24 weeks
Title
Usability of the mCRC system
Description
Participant's rating of the usability of the mCRC system
Time Frame
Day of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Miller, MD, MS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillsdale Family Medicine
City
Advance
State/Province
North Carolina
ZIP/Postal Code
27006
Country
United States
Facility Name
Foothills Family Medicine
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Wilkes Internal Medicine
City
Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Facility Name
Downtown Health Plaza
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Peace Haven Family Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States
Facility Name
Reynolda Family Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29532054
Citation
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.
Results Reference
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Effectiveness of an mHealth Colorectal Cancer Screening Intervention

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