Improving how patients take oral cancer medicines with extra education and support
A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community
NA · Thomas Jefferson University · NCT03245411
This program tests whether adding enhanced education and material support helps adults with advanced cancers and low health literacy take their oral cancer medicines as prescribed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03245411 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial at Albert Einstein Healthcare Network compares standard nurse-delivered education to an enhanced intervention combining simplified, tailored education and material supports to improve adherence to oral anticancer agents. Eligible participants are adults with a range of metastatic solid tumors or hematologic malignancies who are prescribed oral chemotherapy or targeted therapies and have ECOG performance status under 3. Adherence will be tracked over time using patient report and clinic-based monitoring, and the study will examine changes in medication-taking behavior and engagement with care. The program is designed specifically for a medically underserved, low-literacy urban population to produce practical, implementable interventions.
Who should consider this trial
Good fit: Adults (>18 years) on prescribed oral anticancer agents for the listed metastatic or hematologic cancers with ECOG <3, particularly those with low health literacy or limited socioeconomic resources, are the ideal candidates.
Not a fit: Patients not taking oral anticancer agents, those with ECOG ≥3, those receiving concurrent chemoradiation, or patients without the targeted literacy or socioeconomic barriers are less likely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could increase adherence to oral cancer medicines in disadvantaged patients and thereby improve treatment effectiveness and outcomes.
How similar studies have performed: Related multi-level education and material-support interventions have improved screening and adherence in other underserved groups, but randomized trials focused specifically on oral anticancer medication adherence remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients on oral chemotherapeutic agents * Clinical diagnosis of stage IV breast cancer * Clinical diagnosis of stage III and IV colorectal cancer (not receiving concurrent radiation therapy) * Clinical diagnosis of stage IV non-small cell lung cancer * Clinical diagnosis of stage IV renal cell carcinoma * Clinical diagnosis of stage IV ovarian carcinoma * Clinical diagnosis of multiple myeloma * Clinical diagnosis of chronic myelogenous leukemia on TKI * Clinical diagnosis of myelodysplastic syndrome on Lenalidomide * Adjuvant treatment for Gastro Intestinal Stromal Tumor * Clinical diagnosis of chronic Lymphocytic Leukemia * Clinical diagnosis of metastatic Prostate cancer * Clinical diagnosis of hepatocellular Carcinoma * Clinical diagnosis of stage IV Melanoma * Clinical diagnosis of myelofibrosis/myeloproliferative neoplasms * Age \>18 years * ECOG Performance Status \<3 Exclusion Criteria: * ECOG Performance Status of 3 and above * Concurrent chemo radiation * Non-English speaker * Clinical diagnosis of dementia, or otherwise unable to give informed consent. * History of non-compliance (defined as the history of 2 or more missed appointments in the clinic). * Pregnant patients * Nursing Home Patients * Incarcerated
Where this trial is running
Philadelphia, Pennsylvania
- Albert Einstein Healthcare Network — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Claudia M Dourado, MD — Thomas Jefferson University
- Study coordinator: Claudia M Dourado, MD
- Email: Douradoc@einstein.edu
- Phone: 215-456-3880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer