Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-09 @ 4:29 AM
Study NCT ID:
NCT02088333
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2014-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an mHealth Colorectal Cancer Screening Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2014-03-10', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of CRC Screening', 'timeFrame': '24 weeks', 'description': 'Patient completion of a colorectal cancer screening test, such as the fecal occult blood test, a flexible sigmoidoscopy, or a colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'CRC Screening Attitudes and Beliefs', 'timeFrame': 'Day of enrollment', 'description': "A survey scale measuring the participant's attitudes and beliefs about CRC screening"}, {'measure': 'Intention to receive CRC screening', 'timeFrame': 'Day of enrollment', 'description': "Participant's stated intention to receive CRC screening"}, {'measure': 'Self-efficacy', 'timeFrame': 'Day of enrollment', 'description': "Participant's belief that they are capable of completing CRC screening"}, {'measure': 'Ability to make a screening decision', 'timeFrame': 'Day of enrollment'}, {'measure': 'CRC screening discussions', 'timeFrame': 'Up to 5 days', 'description': "Participants' self-report of whether they discussed CRC screening with a medical provider"}, {'measure': 'Satisfaction with screening decision', 'timeFrame': 'Up to 5 days', 'description': 'Survey questions based on the Satisfaction with Decision Scale'}, {'measure': 'CRC screening test order', 'timeFrame': '24 weeks', 'description': 'Whether or not a CRC screening test was ordered for the participant'}, {'measure': 'Cost of the mCRC intervention', 'timeFrame': '24 weeks', 'description': 'Additional cost of the mCRC intervention as captured by additional time and technology costs'}, {'measure': 'Usability of the mCRC system', 'timeFrame': 'Day of enrollment', 'description': "Participant's rating of the usability of the mCRC system"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer screening', 'computer-assisted instruction', 'mHealth', 'text message'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '29532054', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking patients aged 50 - 74 years\n* Scheduled to see a primary care provider for a routine (i.e., non-urgent care) visit\n* Due for colorectal cancer screening\n\nExclusion Criteria:\n\n* A personal history of CRC\n* Specific CRC risk factors, including: First degree relative with CRC; Personal history of adenomatous polyps; Recent blood in stools\n* Obvious physical or mental disability that would prevent participant from interacting with a tablet device.\n* Receipt of treatment for cancer (excluding non-melanoma skin cancers) within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT02088333', 'acronym': 'mCRC', 'briefTitle': 'Effectiveness of an mHealth Colorectal Cancer Screening Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Primary Care Multilevel mHealth Colorectal Cancer Screening (mCRC) Intervention', 'orgStudyIdInfo': {'id': 'IRB00023575'}, 'secondaryIdInfos': [{'id': '1R01CA178941', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA178941', 'type': 'NIH'}, {'id': 'CCCWFU 59A13', 'type': 'OTHER', 'domain': 'Wake Forest Baptist Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mCRC intervention', 'description': 'intervention arm', 'interventionNames': ['Behavioral: mCRC intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy lifestyles education', 'description': 'tablet-based patient education about healthy lifestyles', 'interventionNames': ['Behavioral: Healthy Lifestyles video']}], 'interventions': [{'name': 'mCRC intervention', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['mCRC intervention']}, {'name': 'Healthy Lifestyles video', 'type': 'BEHAVIORAL', 'description': 'a brief video about healthy lifestyle habits displayed on a tablet device', 'armGroupLabels': ['Healthy lifestyles education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27006', 'city': 'Advance', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hillsdale Family Medicine', 'geoPoint': {'lat': 35.94125, 'lon': -80.40922}}, {'zip': '27030', 'city': 'Mount Airy', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Foothills Family Medicine', 'geoPoint': {'lat': 36.4993, 'lon': -80.60729}}, {'zip': '28659', 'city': 'Wilkesboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilkes Internal Medicine', 'geoPoint': {'lat': 36.14596, 'lon': -81.16064}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Downtown Health Plaza', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Peace Haven Family Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Reynolda Family Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David P Miller, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'University of North Carolina, Charlotte', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}