Clinical trial · Interventional
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
NCT05886764CI-TRIAL-00109514active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Community Outreach | Other | — | UNRESOLVED |
| Digital Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm 1 (No Intervention)
- description
- 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.
- type
- EXPERIMENTAL
- label
- Arm 2 (Digital Intervention)
- description
- 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.
- interventionNames
- Other: Digital Intervention
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Patient Subjects: * 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 Inclusion Criteria for Provider Subjects: * oncology provider at study site scheduled to see patients meeting criteria above Exclusion Criteria for Patient Subjects: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.