CancerNCT05886764
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
A study testing Digital Intervention and Community Outreach in people with Cancer and Malignancy, run by University of Chicago at 1 site in United States.
Trial summary
This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Malignancy, Malignant Neoplasm
- What is being tested?
- Digital Intervention and Community Outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Self-described African American race (patients who self-describe as "more than one race" will be included)
- Scheduled for new or consult oncology appointment at the study site
- Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.
- for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
- other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site
- oncology provider at study site scheduled to see patients meeting criteria above
Who cannot join
- Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
- Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
- Initiated new anti-cancer therapy within last 2 months
- Evaluated for possible enrollment/randomization in the last 2 months
- Prior enrollment/randomization on this recruitment trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).
- Conditions
- Cancer, Malignancy, Malignant Neoplasm
- Being tested
- Digital Intervention, Community Outreach
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital InterventionOther
Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Community OutreachOther
Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (No Intervention) | No intervention | Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods. Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. |
| Arm 2 (Digital Intervention) | Experimental | Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. Receives: Other: Digital Intervention |
| Arm 3 (Digital Intervention + Community Outreach) | Experimental | Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.
Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. Receives: Other: Digital Intervention; Other: Community Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that enroll to early phase cancer treatment clinical trials.
Measured: within 2 months of randomization
Secondary outcomes (3)
Number of successfully completed outreach efforts
Measured: after 30 participants are enrolled to each of arms 2 and 3
Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.
Measured: 2 years from randomization
Percent change in number of African Americans that enroll to cancer clinical trials
Measured: 2 years after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start23 Oct 2023
- Primary completion26 Feb 2026
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer
- Responsible party
- Sponsor
- Investigators
- Briseis Aschebrook-Kilfoy, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886764
- Sponsor's protocol ID
- IRB23-0221
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2023
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
- ClinicalTrials.gov ID
- NCT05886764
- Acronym / sponsor ID
- IRB23-0221
- Conditions
- Cancer, Malignancy, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Stand Up To Cancer
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 2 Jun 2023 (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.
This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (No Intervention) | No intervention | –Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods. Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. |
| Arm 2 (Digital Intervention) | Experimental | Other: Digital InterventionPatient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. |
| Arm 3 (Digital Intervention + Community Outreach) | Experimental | Other: Digital Intervention, Other: Community OutreachPatient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Self-described African American race (patients who self-describe as "more than one race" will be included)
- Scheduled for new or consult oncology appointment at the study site
- Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.
- other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site
Key exclusion criteria (5 listed)
- Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
- Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
- Initiated new anti-cancer therapy within last 2 months
- Evaluated for possible enrollment/randomization in the last 2 months
- Prior enrollment/randomization on this recruitment trial
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 |
|---|---|---|
| Digital InterventionDigital messages (email, text, etc.) which include general educational information about clinical trials and available resources. | Other | Arm 2 (Digital Intervention), Arm 3 (Digital Intervention + Community Outreach) |
| Community OutreachInvitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial. | Other | Arm 3 (Digital Intervention + Community Outreach) |
Primary outcome
Percentage of patients that enroll to early phase cancer treatment clinical trials.
Time frame: within 2 months of randomization
3 secondary outcomes
Number of successfully completed outreach efforts
Time frame: after 30 participants are enrolled to each of arms 2 and 3
Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.
Time frame: 2 years from randomization
Percent change in number of African Americans that enroll to cancer clinical trials
Time frame: 2 years after study start
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 27 Apr 2026.
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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.
Briseis Aschebrook-Kilfoy principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention and Community Outreach in people with Cancer and Malignancy, run by University of Chicago 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 7 inclusion and 5 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 27 Apr 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?
Percentage of patients that enroll to early phase cancer treatment clinical trials. (time frame: within 2 months of randomization). 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 27 Apr 2026.