CancerNCT05645328
Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural Patients
A study testing Iowa Cancer Affiliate Network (ICAN) in people with Cancer, run by Mary Charlton at 1 site in United States.
Trial summary
The purpose of this study is to implement and evaluate the recently developed Iowa Cancer Affiliate Network (ICAN) intervention. The ICAN intervention will consist of members of the research team providing ongoing support to participating hospitals in achieving the quality standards outlined by the American College of… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer
- What is being tested?
- Iowa Cancer Affiliate Network (ICAN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Administrators, clinicians, and data monitoring staff who help provide cancer related care at one of the four hospitals that have been included in our study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural, Underserved Patients
The purpose of this study is to implement and evaluate the recently developed Iowa Cancer Affiliate Network (ICAN) intervention.
The ICAN intervention will consist of members of the research team providing ongoing support to participating hospitals in achieving the quality standards outlined by the American College of Surgeons Commission on Cancer (CoC). Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements.
Read more
Implementation approach:1) Engage implementation teams and develop and execute implementation plans based on hospital needs assessments; and 2) Conduct interviews with key ICAN stakeholders to assess acceptability, adoption, appropriateness and cost (based on Proctor's implementation outcomes framework) and determinants of these outcomes (e.g., hospital structure, culture, resources, capacity, readiness) based on the Consolidated Framework for Implementation Research.
Evaluation approach: Using Iowa Cancer Registry data routinely collected for surveillance purposes, the investigators will compare rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals. The rural hospitals in Iowa that serve the most rural cancer patients and have never been accredited by the CoC were chosen for intervention targets, and all committed to participating in the study (letters of support provided). The remainder of rural hospitals that care for >100 newly diagnosed cancer patients per year (n=5) were chosen as a comparison group. The investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and comparison group hospitals using a difference-in-difference estimator. In addition, the investigators will conduct interviews with representatives from intervention hospitals to assess the extent to which ICAN hospitals implemented the CoC standards of cancer care.
Read the detailed description
Intervention: The investigators received letters of support from hospitals, and those who direct the cancer center staff have expressed their willingness to participate on behalf of their staff. This is a health-system-level intervention, designed as single-arm intervention trial, where five participating hospitals will be offered support in the areas of training and education, cancer data collection and reporting, quality improvement and clinical peer-to-peer support.
The ICAN intervention was developed through implementation science processes as an adaptation of the Markey Cancer Center Affiliate Network (MCCAN) with retention of identified core functions. Each hospital in the intervention arm has undergone interviews about their current cancer program needs and offerings. From the information gathered through these meetings, the investigators established baseline understandings of cancer centers and their services. Through these meetings, the investigators elicited program goals, challenges, and readiness for change within their cancer services. Prior to starting the ICAN intervention, the cancer centers will be provided a documentation specifying current status for meeting CoC accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. Through the intervention, each of the five hospitals will be offered support, expertise, and resources necessary to facilitate hospitals in achieving the standards set forth by the American College of Surgeons Commission on Cancer. Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements. The specific intervention actions will be tailored to the needs identified for each hospital or health system based on particular standards they currently do not meet and choose to work toward.
4 years from the start of the intervention, the investigators will use Iowa Cancer Registry data to evaluate the success of the intervention by comparing rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals using a difference-in-difference estimator. The rural hospitals in Iowa that serve the most rural cancer patients (all care for >100 newly diagnosed cancer patients per year) and have never been accredited by the CoC were chosen for intervention targets. The remainder of rural hospitals that care for >100 newly diagnosed cancer patients per year (n=4) were chosen as a comparison group. They were not contacted, as they will not be providing us with any data. Rather, the investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and hospitals that were not.
These variables needed to compute compliance with quality measures by hospital are routinely collected by the Iowa Cancer Registry from all hospitals in Iowa as part of routine public health surveillance. The investigators will only be using data provided to us by the Iowa Cancer Registry to calculate these measures for both intervention and control hospitals and will not be accessing medical record data from the intervention or control hospitals.
Interviews: Subjects from intervention hospitals will be asked to reply to the recruitment email and provide times over the subsequent two weeks that would for them to participate in a one-time audio/video-recorded telephone interview which will take approximately 30-45 minutes. Subjects will be asked prior to recording whether recording is permitted. If permitted, the interview will be recorded on zoom and converted to an audio file using UI (University of Iowa)-Capture. The recordings will be used to audio-transcribe the interview so that they transcript can be used in qualitative data-analysis. Only members of the research team will have access to the recordings. The audio-transcriptions will be done using the web-based service Rev.com. The recordings will be destroyed on completion of the data-analysis. The interview will include questions about the culture, structure, changes and current processes at their hospital for providing cancer care and the impact of the intervention. They will be mailed a $50 check in appreciation of their time after the interview has been conducted. There will be no additional follow-up to the interviews.
- Conditions
- Cancer
- Being tested
- Iowa Cancer Affiliate Network (ICAN)
- Keywords
- Health system intervention, Rural health, Quality improvement, Implementation science
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iowa Cancer Affiliate Network (ICAN)Other
Each hospital in the intervention has undergone interviews in which the investigators elicited program goals, challenges, and readiness for change. Prior to the intervention, the cancer centers will be provided a document specifying current status for meeting Commission on Cancer (CoC) accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. The hospitals will be offered support, expertise, and resources to facilitate them in achieving the CoC standards. Support will be offered in the form of education/training regarding the standards and provision of cancer services, regular in-person/zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation/educational resources regarding standard requirements. The intervention actions will be tailored to the needs of each hospital based on standards they currently do not meet and choose to work toward.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Hospital Administrators, Providers, and Data Monitoring Staff | Experimental | This is a health-system-level intervention, designed as two-arm intervention trial, where four participating hospitals will be offered support in the areas of training and education, cancer data collection and reporting, quality improvement and clinical peer-to-peer support.
Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. We selected 4 of the 9 rural hospitals meeting this criteria to administer the intervention. Receives: Other: Iowa Cancer Affiliate Network (ICAN) |
| Control arm | No intervention | Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. The remaining 5 hospitals meeting this criteria that were not selected for the intervention will serve as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with CoC quality of cancer care measures: Hormone therapy (HT)
primary quality measure for breast cancer: percent of patients receiving tamoxifen or 3rd gen aromatase inhibitor within 1 year of diagnosis for women with T1cN0M0 or stage IB-III hormone receptor-positive cancer
Measured: 36 months post implementation of intervention
Compliance with CoC quality of cancer care measures: 12 regional lymph nodes (12RLN)
primary quality measure for colon cancer: percent of patients having >12 regional lymph nodes removed and examined
Measured: 36 months post implementation of intervention
Secondary outcomes (4)
Compliance with CoC quality of cancer care measures: Breast conserving surgery radiation therapy (BCSRT)
percent of patients receiving radiation within 1 year of diagnosis for women <70 years old receiving breast conserving surgery for breast cancer
Measured: 36 months post implementation of intervention
Compliance with CoC quality of cancer care measures: Multi-agent chemotherapy (MAC)
percent of patients receiving combination chemomotherapy within 4 months of diagnosis for women <70 years old with T1cN0M0 or stage IB-III hormone receptor-negative breast cancer
Measured: 36 months post implementation of intervention
Compliance with CoC quality of cancer care measures: Adjuvant chemotherapy (ACT)
percent of patients receiving adjuvant chemotherapy within 4 months of diagnosis for patients <80 years old with AJCC Stage III (lymph node positive) colon cancer
Measured: 36 months post implementation of intervention
Percentage of CoC evidence-based standards of cancer care implemented
Number and percentage of the 38 evidence-based CoC standards being met by each hospital
Measured: 36 months post implementation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start20 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Charlton
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Mary Charlton, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645328
- Sponsor's protocol ID
- 202202104
- Other IDs
- R01CA254628
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schroeder MC, Birken SA, Lizarraga IM, Kirk MA, Wagi CR, Engelbart JM, Johnson EC, Wahlen MM, Seaman AT, Charlton ME. Application of MODIFI to the adaptation of a complex, multilevel intervention to enhance access to high-quality cancer services in rural cancer hospitals. Implement Sci Commun. 2025 Oct 16;6(1):105. doi: 10.1186/s43058-025-00805-x.
PubMed 41102855
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural, Underserved Patients
- ClinicalTrials.gov ID
- NCT05645328
- Acronym / sponsor ID
- 202202104
- Conditions
- Cancer
- Keywords
- Health system intervention, Rural health, Quality improvement, Implementation science
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mary CharltonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to implement and evaluate the recently developed Iowa Cancer Affiliate Network (ICAN) intervention.
The ICAN intervention will consist of members of the research team providing ongoing support to participating hospitals in achieving the quality standards outlined by the American College of Surgeons Commission on Cancer (CoC). Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements.
Implementation approach:1) Engage implementation teams and develop and execute implementation plans based on hospital needs assessments; and 2) Conduct interviews with key ICAN stakeholders to assess acceptability, adoption, appropriateness and cost (based on Proctor's implementation outcomes framework) and determinants of these outcomes (e.g., hospital structure, culture, resources, capacity, readiness) based on the Consolidated Framework for Implementation Research.
Evaluation approach: Using Iowa Cancer Registry data routinely collected for surveillance purposes, the investigators will compare rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals. The rural hospitals in Iowa that serve the most rural cancer patients and have never been accredited by the CoC were chosen for intervention targets, and all committed to participating in the study (letters of support provided). The remainder of rural hospitals that care for >100 newly diagnosed cancer patients per year (n=5) were chosen as a comparison group. The investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and comparison group hospitals using a difference-in-difference estimator. In addition, the investigators will conduct interviews with representatives from intervention hospitals to assess the extent to which ICAN hospitals implemented the CoC standards of cancer care.
Detailed description
Intervention: The investigators received letters of support from hospitals, and those who direct the cancer center staff have expressed their willingness to participate on behalf of their staff. This is a health-system-level intervention, designed as single-arm intervention trial, where five participating hospitals will be offered support in the areas of training and education, cancer data collection and reporting, quality improvement and clinical peer-to-peer support.
The ICAN intervention was developed through implementation science processes as an adaptation of the Markey Cancer Center Affiliate Network (MCCAN) with retention of identified core functions. Each hospital in the intervention arm has undergone interviews about their current cancer program needs and offerings. From the information gathered through these meetings, the investigators established baseline understandings of cancer centers and their services. Through these meetings, the investigators elicited program goals, challenges, and readiness for change within their cancer services. Prior to starting the ICAN intervention, the cancer centers will be provided a documentation specifying current status for meeting CoC accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. Through the intervention, each of the five hospitals will be offered support, expertise, and resources necessary to facilitate hospitals in achieving the standards set forth by the American College of Surgeons Commission on Cancer. Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements. The specific intervention actions will be tailored to the needs identified for each hospital or health system based on particular standards they currently do not meet and choose to work toward.
4 years from the start of the intervention, the investigators will use Iowa Cancer Registry data to evaluate the success of the intervention by comparing rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals using a difference-in-difference estimator. The rural hospitals in Iowa that serve the most rural cancer patients (all care for >100 newly diagnosed cancer patients per year) and have never been accredited by the CoC were chosen for intervention targets. The remainder of rural hospitals that care for >100 newly diagnosed cancer patients per year (n=4) were chosen as a comparison group. They were not contacted, as they will not be providing us with any data. Rather, the investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and hospitals that were not.
These variables needed to compute compliance with quality measures by hospital are routinely collected by the Iowa Cancer Registry from all hospitals in Iowa as part of routine public health surveillance. The investigators will only be using data provided to us by the Iowa Cancer Registry to calculate these measures for both intervention and control hospitals and will not be accessing medical record data from the intervention or control hospitals.
Interviews: Subjects from intervention hospitals will be asked to reply to the recruitment email and provide times over the subsequent two weeks that would for them to participate in a one-time audio/video-recorded telephone interview which will take approximately 30-45 minutes. Subjects will be asked prior to recording whether recording is permitted. If permitted, the interview will be recorded on zoom and converted to an audio file using UI (University of Iowa)-Capture. The recordings will be used to audio-transcribe the interview so that they transcript can be used in qualitative data-analysis. Only members of the research team will have access to the recordings. The audio-transcriptions will be done using the web-based service Rev.com. The recordings will be destroyed on completion of the data-analysis. The interview will include questions about the culture, structure, changes and current processes at their hospital for providing cancer care and the impact of the intervention. They will be mailed a $50 check in appreciation of their time after the interview has been conducted. There will be no additional follow-up to the interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Hospital Administrators, Providers, and Data Monitoring Staff | Experimental | Other: Iowa Cancer Affiliate Network (ICAN)This is a health-system-level intervention, designed as two-arm intervention trial, where four participating hospitals will be offered support in the areas of training and education, cancer data collection and reporting, quality improvement and clinical peer-to-peer support. Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. We selected 4 of the 9 rural hospitals meeting this criteria to administer the intervention. |
| Control arm | No intervention | –Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. The remaining 5 hospitals meeting this criteria that were not selected for the intervention will serve as controls. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Administrators, clinicians, and data monitoring staff who help provide cancer related care at one of the four hospitals that have been included in our study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Iowa Cancer Affiliate Network (ICAN)Each hospital in the intervention has undergone interviews in which the investigators elicited program goals, challenges, and readiness for change. Prior to the intervention, the cancer centers will be provided a document specifying current status for meeting Commission on Cancer (CoC) accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. The hospitals will be offered support, expertise, and resources to facilitate them in achieving the CoC standards. Support will be offered in the form of education/training regarding the standards and provision of cancer services, regular in-person/zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation/educational resources regarding standard requirements. The intervention actions will be tailored to the needs of each hospital based on standards they currently do not meet and choose to work toward. | Other | Intervention Hospital Administrators, Providers, and Data Monitoring Staff |
Primary outcome
Compliance with CoC quality of cancer care measures: Hormone therapy (HT)
Time frame: 36 months post implementation of intervention
primary quality measure for breast cancer: percent of patients receiving tamoxifen or 3rd gen aromatase inhibitor within 1 year of diagnosis for women with T1cN0M0 or stage IB-III hormone receptor-positive cancer
Compliance with CoC quality of cancer care measures: 12 regional lymph nodes (12RLN)
Time frame: 36 months post implementation of intervention
primary quality measure for colon cancer: percent of patients having >12 regional lymph nodes removed and examined
4 secondary outcomes
Compliance with CoC quality of cancer care measures: Breast conserving surgery radiation therapy (BCSRT)
Time frame: 36 months post implementation of intervention
Compliance with CoC quality of cancer care measures: Multi-agent chemotherapy (MAC)
Time frame: 36 months post implementation of intervention
Compliance with CoC quality of cancer care measures: Adjuvant chemotherapy (ACT)
Time frame: 36 months post implementation of intervention
Percentage of CoC evidence-based standards of cancer care implemented
Time frame: 36 months post implementation of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 41102855Schroeder MC, Birken SA, Lizarraga IM, Kirk MA, Wagi CR, Engelbart JM, Johnson EC, Wahlen MM, Seaman AT, Charlton ME. Application of MODIFI to the adaptation of a complex, multilevel intervention to enhance access to high-quality cancer services in rural cancer hospitals. Implement Sci Commun. 2025 Oct 16;6(1):105. doi: 10.1186/s43058-025-00805-x.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iowa Cancer Affiliate Network (ICAN) in people with Cancer, run by Mary Charlton at 1 site 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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Compliance with CoC quality of cancer care measures: Hormone therapy (HT) (time frame: 36 months post implementation of intervention). The study lists 2 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 NCT05645328, which also lists 1 linked publication.
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 18 Aug 2026.