Colorectal CancerNCT05107661
Colorectal Screening Strategies in Underserved Populations
An observational study of Colorectal Cancer, run by Virtua Health, Inc. at 1 site in United States.
Trial summary
Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations. Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors… Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Telephone Prompt
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2021to 9 Aug 2023
- Phase
- Observational
- 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 45 to 64 years
- All sexes
- Adult
Study population: The target population is economically disadvantaged minority, medically underserved individuals that meet eligibility requirements for participation in the New Jersey Cancer Education Early Detection Program.
Who may be able to join
- Any Gender
- 45-64 years of age
- Able to sign the informed consent form
- Meets eligibility criteria to participate in New Jersey Cancer Education Early Detection Community Outreach Program
- Uninsured/underinsured
- Household income <250% Federal Poverty Level
Show all 9Show fewer
- Must be New Jersy resident
- Must have Smart phone
- Must speak English or Spanish
Who cannot join
- History of colon cancer, colon/rectal polyps and rectal bleeding
- Individuals with Dementia
- ECOG Performance Status 3-4
- Prior Colonoscopy within past 10 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations. Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors early when treatments are most effective.
Read the detailed description
To determine the effectiveness of completion of colorectal cancer screening through fecal testing for blood and/or colonoscopies as a screening intervention utilizing digital reminders versus telephone prompts and reminders in economically disadvantaged minority communities as part of a colorectal screening outreach program.
- Conditions
- Colorectal Cancer
- Being tested
- Telephone Prompt
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone PromptBehavioural
Also called Digital Prompt
Scripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test)
| Study group | Role | What they receive |
|---|---|---|
| Telephone Prompt | Following consent, the Research Team will call participants three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then one time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test). Interpreter services via phone will be utilized for non-English speaking participants. Receives: Behavioral: Telephone Prompt | |
| Digital Prompt | Following consent, scripted messaging will be sent three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then once time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test). Digital prompts will be available in Spanish and English. Receives: Behavioral: Telephone Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
To determine the effectiveness of digital reminders versus telephone reminders to prompt participants to follow through with completing their colonoscopy. Comparison of the success or failure of digital versus phone call reminders will be measured. To determine the effectiveness of digital reminders versus phone reminders to follow through with completing fecal testing to screen for colorectal cancer. Comparison of the success or failure of digital versus phone call reminders will be measured.
Measured: 3 month intervals
Secondary outcomes (1)
Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Which colorectal screening intervention is preferred in the target population: Colonoscopy versus occult fecal testing in the targeted population
- Out comes will be measured by:
- Percentage rates of which screening method is selected by the participant: colonoscopy vs. fecal testing.
- Percentage rates for following through with completing the screening colonoscopy versus occult fecal testing in the targeted population
Measured: 3 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start26 Sep 2021
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Why it stopped: Preliminary findings revealed to many barriers to successfully complete this trial.
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107661
- Sponsor's protocol ID
- IRB-2021-03
- Status last verified
- Dec 2022
- First submitted
- 5 Oct 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
- ClinicalTrials.gov ID
- NCT05107661
- Acronym / sponsor ID
- IRB-2021-03
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary findings revealed to many barriers to successfully complete this trial.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Collaborators
- Rutgers University
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 4 Nov 2021 (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.
Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations. Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors early when treatments are most effective.
Detailed description
To determine the effectiveness of completion of colorectal cancer screening through fecal testing for blood and/or colonoscopies as a screening intervention utilizing digital reminders versus telephone prompts and reminders in economically disadvantaged minority communities as part of a colorectal screening outreach program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Prompt | – | Behavioral: Telephone PromptFollowing consent, the Research Team will call participants three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then one time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test). Interpreter services via phone will be utilized for non-English speaking participants. |
| Digital Prompt | – | Behavioral: Telephone PromptFollowing consent, scripted messaging will be sent three times in the first month (within the first week of signing consent at week 2 and repeated at week 3) and then once time per month for the following two months with scripted messaging reminding the participant to complete the screening activity (colonoscopy or fecal test). Digital prompts will be available in Spanish and English. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- The target population is economically disadvantaged minority, medically underserved individuals that meet eligibility requirements for participation in the New Jersey Cancer Education Early Detection Program.
Key inclusion criteria (9 listed)
- Any Gender
- 45-64 years of age
- Able to sign the informed consent form
- Meets eligibility criteria to participate in New Jersey Cancer Education Early Detection Community Outreach Program
- Must have Smart phone
Key exclusion criteria (4 listed)
- History of colon cancer, colon/rectal polyps and rectal bleeding
- Individuals with Dementia
- ECOG Performance Status 3-4
- Prior Colonoscopy within past 10 years
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 |
|---|---|---|
| Telephone PromptAlso: Digital PromptScripted messaging to remind subjects to complete their colorectal screening (colonoscopy or fecal test) | Behavioural | Digital Prompt, Telephone Prompt |
Primary outcome
: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Time frame: 3 month intervals
To determine the effectiveness of digital reminders versus telephone reminders to prompt participants to follow through with completing their colonoscopy. Comparison of the success or failure of digital versus phone call reminders will be measured. To determine the effectiveness of digital reminders versus phone reminders to follow through with completing fecal testing to screen for colorectal cancer. Comparison of the success or failure of digital versus phone call reminders will be measured.
1 secondary outcome
Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Time frame: 3 month intervals
Results and safety
The study was stopped early (reason given: Preliminary findings revealed to many barriers to successfully complete this trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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?
An observational study of Colorectal Cancer, run by Virtua Health, Inc. 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Aug 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 stopped early (reason given: Preliminary findings revealed to many barriers to successfully complete this trial.). Results are not available in the source record.
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?
: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program (time frame: 3 month intervals). 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 14 Aug 2023.