Clinical trial · Interventional
Lay Health Worker Engage, Educate, and Encourage Patients to Share
NCT03699748CI-TRIAL-00067863LEAPScompletedN/AResults postedClinicalTrials.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)
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
Conditions
Conditions (2)
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 |
| End of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lay Health Worker Intervention | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group Arm
- description
- Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention arm will also receive usual care as provided by Unite Here Health and their local oncologists.
- interventionNames
- Behavioral: Lay Health Worker Intervention
- Other: Usual Care
- type
- ACTIVE_COMPARATOR
- label
- Control Group Arm
- description
- The control group arm will receive usual care as provided by Unite Here Health and their local oncologists.
- interventionNames
- Other: Usual Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed patients with a cancer diagnosis. 2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. 3. The patients must be 18 years or older. 4. Patients must have the capacity to verbally consent. Exclusion Criteria: 1. Inability to consent to the study due to lack of capacity as documented by the referring physician. 2. Patients without a newly diagnosed malignancy or patients without relapse of disease. 3. Patients not eligible for Fund benefits. Patients without a newly diagnosed malignancy or patients without relapse of disease.
References
Publications (2)
- DERIVEDPatel MI, Kapphahn K, Wood E, Coker T, Salava D, Riley A, Krajcinovic I. Effect of a Community Health Worker-Led Intervention Among Low-Income and Minoritized Patients With Cancer: A Randomized Clinical Trial. J Clin Oncol. 2024 Feb 10;42(5):518-528. doi: 10.1200/JCO.23.00309. Epub 2023 Aug 25. PMID 37625110
- DERIVEDPatel MI, Khateeb S, Coker T. A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings. Contemp Clin Trials. 2020 Apr;91:105971. doi: 10.1016/j.cct.2020.105971. Epub 2020 Mar 4. PMID 32145441