Colorectal CancerNCT04535492
Technology-Based Cancer Screening Intervention
A study testing Decision Making Support Tool in people with Colorectal Cancer and Lung Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- Decision Making Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Breast Cancer Screening:
Inclusion Criteria: women 50-74 years old Exclusion Criteria: current breast cancer diagnosis, mastectomy
Colorectal Cancer Screening:
Inclusion Criteria: adults 50-74 years Exclusion Criteria: colorectal cancer diagnosis
Lung Cancer Screening:
Inclusion Criteria: adult 55-80 years old with 30 pack per year history who currently smoke or quit within the last 15 years.
Exclusion Criteria: lung cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Improving Cancer Screening Through A Tailored Technology-Based Intervention
The primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients. The goal of the clinical trial is to evaluate (prove) the effectiveness of this shared-decision making support tool developed in EPIC on the rate of recommended cancer screening in practice. It contributes to knowledge on what specific methods can increase patient adherence to recommended preventive care and reduce disparities.
Read the detailed description
Patients seen at primary care practices, who have been pre-determined to have unmet screening requirements and have received standard of care with a QI tool, will be asked to complete an optional questionnaire electronically through a patient portal or via a link sent by text within a week of their visit, based on their preference. Only those who have indicated they agree to be contacted for research purposes will be contacted. Surveys will be distributed through REDCap so no identifying information will be contained in the answers. REDCap is a free, HIPAA compliant interface for building and managing online databases. Additionally, surveys will be sent via mail if the patient cannot be reached electronically. Survey responses received through the mail will not include any identifying information. Pre-paid return envelopes will be provided to preserve anonymity. Although a small proportion of South Carolina's population are primary Spanish speakers (about 4%), to be inclusive we want to ensure all materials are available in Spanish. To remove barriers to participation, those needing physical, hearing, and visual assistance will be able to review and complete documents at the time of their clinic visit with the assistance of trained study personnel. Invitations will continue to be sent out until 100 total patient responses are received per practice in the pragmatic trial, or 50 per practice in the pilot. Clinicians will also receive a survey to assess the tool. Recruitment for clinicians surveys will be done via email sent by the practice managers to the providers who have agreed to use the QI tool. Clinician assessments will be delivered electronically via a link delivery by email or text, or sent by mail, based on clinician preference. Respondents will be reimbursed for their time and effort. These assessments will be anonymous. Survey participation will be coded in order to provide compensation. Since data will be identified only by code numbers (participant IDs) the master list of those codes will be kept physically separate from the collected data.
- Conditions
- Colorectal Cancer, Lung Cancer, Breast Cancer
- Being tested
- Decision Making Support Tool
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Making Support ToolBehavioural
Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Screening Recommended | Other | The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years. Receives: Behavioral: Decision Making Support Tool |
| Lung Cancer Screening Recommended | Other | The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Receives: Behavioral: Decision Making Support Tool |
| Breast Cancer Screening Recommended | Other | The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. Receives: Behavioral: Decision Making Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient.
Successful completion rate per practice involved, based on eligible patients.
Measured: Duration of the study, a total of five years.
Rate of successful completion of lung cancer screening noted via electronic health record having low dose computed tomography of the chest result for the patient.
Successful completion rate per practice involved, based on eligible patients.
Measured: Duration of the study, a total of five years.
Rate of successful completion of colorectal cancer screening noted via electronic health record having colonoscopy, fecal occult blood, or non invasive screening option result for the patient.
Successful completion rate per practice involved, based on eligible patients.
Measured: Duration of the study, a total of five years.
Secondary outcomes (2)
Average score of patient experience and satisfaction as assessed via Likert scale survey.
A 23 item survey with Likert scale question is used to compiled the patient response: 23 is the lowest score and represent dissatisfaction and 115 is the highest score and represent satisfaction. Participants will have the option to enter text for qualitative feedback and analysis.
Measured: Duration of the study, a total five years.
Average score of clinician experience and satisfaction as assessed via Likert scale survey.
A 20 item survey with Likert scale question is used to compiled the patient response: 20 is the lowest score and represent dissatisfaction and 100 is the highest score and represent satisfaction. Participants will have the option to enter text for qualitative feedback and analysis.
Measured: Duration of the study, a total five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start4 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: No further funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Vanessa Diaz, Medical University of South Carolina
- Investigators
- Vanessa Diaz, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535492
- Sponsor's protocol ID
- 00101494
- Other IDs
- 1R61AG068951
- Status last verified
- May 2023
- First submitted
- 27 Aug 2020
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataverse, an open source research data repository, will be used to archive and share de-identified participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Screening Through A Tailored Technology-Based Intervention
- ClinicalTrials.gov ID
- NCT04535492
- Acronym / sponsor ID
- 00101494
- Conditions
- Colorectal Cancer, Lung Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No further funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Sep 2020 (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 primary purpose of this research study is to contribute to generalized knowledge on how to increase screening for patients at risk of missing their recommended cancer preventive care by using a newly developed predictive model and analytic tool to improve shared decision-making for these patients. The goal of the clinical trial is to evaluate (prove) the effectiveness of this shared-decision making support tool developed in EPIC on the rate of recommended cancer screening in practice. It contributes to knowledge on what specific methods can increase patient adherence to recommended preventive care and reduce disparities.
Detailed description
Patients seen at primary care practices, who have been pre-determined to have unmet screening requirements and have received standard of care with a QI tool, will be asked to complete an optional questionnaire electronically through a patient portal or via a link sent by text within a week of their visit, based on their preference. Only those who have indicated they agree to be contacted for research purposes will be contacted. Surveys will be distributed through REDCap so no identifying information will be contained in the answers. REDCap is a free, HIPAA compliant interface for building and managing online databases. Additionally, surveys will be sent via mail if the patient cannot be reached electronically. Survey responses received through the mail will not include any identifying information. Pre-paid return envelopes will be provided to preserve anonymity. Although a small proportion of South Carolina's population are primary Spanish speakers (about 4%), to be inclusive we want to ensure all materials are available in Spanish. To remove barriers to participation, those needing physical, hearing, and visual assistance will be able to review and complete documents at the time of their clinic visit with the assistance of trained study personnel. Invitations will continue to be sent out until 100 total patient responses are received per practice in the pragmatic trial, or 50 per practice in the pilot. Clinicians will also receive a survey to assess the tool. Recruitment for clinicians surveys will be done via email sent by the practice managers to the providers who have agreed to use the QI tool. Clinician assessments will be delivered electronically via a link delivery by email or text, or sent by mail, based on clinician preference. Respondents will be reimbursed for their time and effort. These assessments will be anonymous. Survey participation will be coded in order to provide compensation. Since data will be identified only by code numbers (participant IDs) the master list of those codes will be kept physically separate from the collected data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Screening Recommended | Other | Behavioral: Decision Making Support ToolThe USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years. |
| Lung Cancer Screening Recommended | Other | Behavioral: Decision Making Support ToolThe USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. |
| Breast Cancer Screening Recommended | Other | Behavioral: Decision Making Support ToolThe USPSTF recommends biennial screening mammography for women aged 50 to 74 years. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Decision Making Support ToolPrimary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients. | Behavioural | Breast Cancer Screening Recommended, Colorectal Cancer Screening Recommended, Lung Cancer Screening Recommended |
Primary outcome
Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient.
Time frame: Duration of the study, a total of five years.
Successful completion rate per practice involved, based on eligible patients.
Rate of successful completion of lung cancer screening noted via electronic health record having low dose computed tomography of the chest result for the patient.
Time frame: Duration of the study, a total of five years.
Successful completion rate per practice involved, based on eligible patients.
Rate of successful completion of colorectal cancer screening noted via electronic health record having colonoscopy, fecal occult blood, or non invasive screening option result for the patient.
Time frame: Duration of the study, a total of five years.
Successful completion rate per practice involved, based on eligible patients.
2 secondary outcomes
Average score of patient experience and satisfaction as assessed via Likert scale survey.
Time frame: Duration of the study, a total five years.
Average score of clinician experience and satisfaction as assessed via Likert scale survey.
Time frame: Duration of the study, a total five years.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes. Dataverse, an open source research data repository, will be used to archive and share de-identified participant data.
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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.
Vanessa Diaz, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Making Support Tool in people with Colorectal Cancer and Lung Cancer, run by Medical University of South Carolina 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?
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: withdrawn, as of the sponsor's last update on 11 May 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of successful completion of breast cancer screening noted via electronic health record having mammogram result for the patient. (time frame: Duration of the study, a total of five years.). 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?
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 11 May 2023.