Colorectal CancerACCSISNCT04427527

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

A study testing Multi-level intervention to increase CRC screening in people with Colorectal Cancer, run by Mark Dignan, PhD at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 74 yearsHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer
What is being tested?: Multi-level intervention to increase CRC screening
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29,772 participants
Where: 2 sitesUnited States
Study dates: 19 Aug 2020to 31 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

age 50-74
all races, sexes and genders
resident of the study area

Who cannot join

.no exclusions based on gender, race or ethnicity

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ohio State University
Columbus, Ohio, 43210
Markey Cancer Center
Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Conditions: Colorectal Cancer
Being tested: Multi-level intervention to increase CRC screening
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multi-level intervention to increase CRC screeningBehavioural
Intervention for the community, providers, patients, clinics and systems

Study groups in NCT04427527
Study group	Role	What they receive
Multi-level Intervention	Experimental	Receives the project intervention first Receives: Behavioral: Multi-level intervention to increase CRC screening
Delayed Multi-level Intervention	No intervention	Offered the intervention later in the project

What is being measured

The primary outcome is the main question the study is designed to answer.

CRC Screening - Clinic Level
This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Measured: Y1 Follow-up
CRC Screening - Clinic Level
This is the Y2 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Measured: Y2 Follow-up
CRC Screening - Clinic Level
This is the baseline clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
Measured: Y0 Baseline

Secondary outcomes (3)

CRC Screening - Community (County) Level
Weighted estimates of clinic-level CRC screening status (within/not within CRC Screening Guidelines) among adults aged 50-74 were calculated from survey data collected in Pair 2 and Pair 3 counties. Estimates were weighted using balancing weights and county/state-level weighting factors to account for sampling design and oversampling. Reported values are weighted mean estimates with 95% confidence intervals and are not participant-level percentages.
Measured: Y0 Baseline
CRC Screening - Community Level
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Measured: Y2 Follow-up
CRC Screening - Community Level
Weighted county-level estimates of CRC screening within screen guidelines among adults age 50-74. Estimates were calculated using balancing weights to account for age/sex representation within counties and county/state weighting factors to account for oversampling. Therefore, weighted estimates and confidence intervals are not restricted to the range 0-100 and should not be interpreted as raw percentages of survey participants.
Measured: Y1 Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202031 Mar 2025

First posted11 Jun 2020
Study start19 Aug 2020
Primary completion31 Mar 2025
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: Primary care clinics randomized to intervention or usual care
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 29,772 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04427527
Sponsor's protocol ID: 2018C0166
Other IDs: UH3CA233282, 832127323
Acronym: ACCSIS
Status last verified: Aug 2026
First submitted: 3 Jun 2020
Last updated: 4 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Notice of Award.

Publications

Paskett ED, Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Gray DM, Pennell ML, Huang B, Young GS, Fickle D, Cromo M, Katz ML, Reiter PL, Rogers M, Gross DA, Fairchild V, Xu W, Carman A, Walunis JM, McAlearney AS, Huerta TR, Rahurkar S, Biederman E, Dignan M. Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial. Transl Behav Med. 2023 Sep 28;13(10):748-756. doi: 10.1093/tbm/ibad017.
PubMed 37202831
Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8.
PubMed 34011410

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)
ClinicalTrials.gov ID: NCT04427527
Acronym / sponsor ID: ACCSIS / 2018C0166
Conditions: Colorectal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 29,772 participants (actual)
Lead sponsor: Mark Dignan, PhDUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Ohio State University
Study start: 19 Aug 2020 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 11 Jun 2020 (actual)
Results: Posted 4 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Primary care clinics randomized to intervention or usual care

Arm	Type	Receives
Multi-level Intervention	Experimental	Behavioral: Multi-level intervention to increase CRC screeningReceives the project intervention first
Delayed Multi-level Intervention	No intervention	–Offered the intervention later in the project

Who may qualify

Ages: 50 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

age 50-74
all races, sexes and genders
resident of the study area

Key exclusion criteria (1 listed)

.no exclusions based on gender, race or ethnicity

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
Multi-level intervention to increase CRC screeningIntervention for the community, providers, patients, clinics and systems	Behavioural	Multi-level Intervention

Primary outcome

CRC Screening - Clinic Level
Time frame: Y1 Follow-up
This is the Y1 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
CRC Screening - Clinic Level
Time frame: Y2 Follow-up
This is the Y2 follow-up clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).
CRC Screening - Clinic Level
Time frame: Y0 Baseline
This is the baseline clinic-reported aggregated CRC screening rate for eligible patients age 50-74 at the clinic-level for Pair 2 and Pair 3 early and delayed clinics (n=8). Pair 1 clinics (n=4) were excluded. Percentages reported are based on aggregated numerator (total # of patients age 50-74 screened for CRC at Pair 2 and 3 early/delayed clinics)/aggregated denominator (total # of patients age 50-74 eligible for CRC screening at Pair 2 and 3 early/delayed clinics).

3 secondary outcomes

CRC Screening - Community (County) Level
Time frame: Y0 Baseline
CRC Screening - Community Level
Time frame: Y2 Follow-up
CRC Screening - Community Level
Time frame: Y1 Follow-up

Results and safety

Results posted to the registry on 4 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baseline Phase	7,692	7,692
Early Intervention	0	0
Delayed Intervention	0	0

Primary outcome: CRC Screening - Clinic Level

Time frame: Y1 Follow-up. Mean (95% Confidence Interval). Unit: Percentage of participants

Measure	Early Intervention Group n = 3035	Delayed Intervention Group n = 5847
Value	47.2 (14.8 to 79.5)	44.6 (13.3 to 75.9)

Population analysed: The analysis included de-identified electronic health record data from 3 Early Intervention clinics and 4 Delayed Intervention clinics during the Y1 follow-up period. Pair 1 clinics (n=4) were excluded and one Pair 2 Early Intervention clinic did not submit Y1 data. The Overall Number of Participants Analyzed represents the total number of eligible patients aged 50-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.

Primary outcome: CRC Screening - Clinic Level

Time frame: Y2 Follow-up. Mean (95% Confidence Interval). Unit: Percent of participants

Measure	Early Intervention Group n = 4130	Delayed Intervention Group n = 6680
Value	46.9 (15.2 to 78.6)	47.7 (16.7 to 78.8)

Population analysed: The analysis included de-identified electronic health record data from 4 Early Intervention clinics and 4 Delayed Intervention clinics during the Y2 follow-up period. Pair 1 clinics (n=4) were excluded. The Overall Number of Participants Analyzed represents the total number of eligible patients aged 50-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.

Primary outcome: CRC Screening - Clinic Level

Time frame: Y0 Baseline. Mean (95% Confidence Interval). Unit: Percentage of participants

Measure	Early Intervention Group n = 2704	Delayed Intervention Group n = 3797
Value	33.6 (0.5 to 66.7)	44.6 (13.4 to 75.7)

Population analysed: Analysis included de-identified EHR data from 3 Early Intervention clinics and 3 Delayed Intervention clinics during the Y0 Baseline period. Pair 1 clinics (n=4) were excluded. One Early Intervention clinic and one Delayed Intervention clinics didn't contribute Y0 data. Overall Number of Participants Analyzed represents the total number of eligible patients aged 500-74 at the analyzed clinics. The reported values are mean clinic-level CRC screening rates and not participant-level percentages.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Intervention	0 of 0	0 of 0	0
Delayed Intervention	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The original intention of this study was to calculate the clinic-level CRC screening rate before and after the MLI based on individual patient-level electronic health record data from participating clinics in each county (primary outcome). However, due to difficulties in retrieving patient-level electronic health record data from clinics, clinics were asked to provide aggregated self-reported annual CRC screening data that was ultimately used to calculate CRC screening rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37202831Paskett ED, Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Gray DM, Pennell ML, Huang B, Young GS, Fickle D, Cromo M, Katz ML, Reiter PL, Rogers M, Gross DA, Fairchild V, Xu W, Carman A, Walunis JM, McAlearney AS, Huerta TR, Rahurkar S, Biederman E, Dignan M. Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) in Appalachia: protocol for a group randomized, delayed intervention trial. Transl Behav Med. 2023 Sep 28;13(10):748-756. doi: 10.1093/tbm/ibad017.
Derived from this study: PubMed 34011410Kruse-Diehr AJ, Oliveri JM, Vanderpool RC, Katz ML, Reiter PL, Gray DM 2nd, Pennell ML, Young GS, Huang B, Fickle D, Cromo M, Rogers M, Gross D, Gibson A, Jellison J, Sarap MD, Bivens TA, McGuire TD, McAlearney AS, Huerta TR, Rahurkar S, Paskett ED, Dignan M. Development of a multilevel intervention to increase colorectal cancer screening in Appalachia. Implement Sci Commun. 2021 May 19;2(1):51. doi: 10.1186/s43058-021-00151-8.
Individual participant dataSharing planned: Yes. As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium. Dataset Items in the LDS are defined by the Common Data Elements. There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers. In addition, all data that underlie results in publications will be available per Notice of Award.

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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.

Mark B Dignan, PhD principal investigator

University of Kentucky

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multi-level intervention to increase CRC screening in people with Colorectal Cancer, run by Mark Dignan, PhD at 2 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 1 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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?

Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

CRC Screening - Clinic Level (time frame: Y1 Follow-up). The study lists 3 primary outcomes in all. 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 NCT04427527, which also lists 2 linked publications.

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 4 Sep 2026.