Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/28/2018 |
| Start Date: | July 20, 2017 |
| End Date: | July 20, 2019 |
| Contact: | Jean G Ford, MD |
| Email: | FordJean@einstein.edu |
| Phone: | 215-456-3466 |
A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community
Einstein Medical Center in Philadelphia serves a diverse group of the patient population. The
majority of patients have a diverse cultural background, low literacy, and poor
social-economic status. Medication adherence for chronic medical problems is in a range of
40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in
detail. The main objective is to study medication adherence to oral anticancer agents in
patients with low literacy and poor socio-economic status.
majority of patients have a diverse cultural background, low literacy, and poor
social-economic status. Medication adherence for chronic medical problems is in a range of
40-70%. Medication adherence among patients on oral anti-cancer therapy is not studied in
detail. The main objective is to study medication adherence to oral anticancer agents in
patients with low literacy and poor socio-economic status.
Until recently, contemporary approaches to cancer care have failed to consistently tailor
communication approaches to patients with low health literacy. They have produced mixed
results in regard to implementation of successful interventions in addressing the needs of
this populations. Low health literacy is especially common in medically underserved
communities, including in North Philadelphia. Cancer treatment, including cancer
chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere
to care and achieve the goals of therapy. Patients with low health literacy find it
especially challenging to navigate cancer treatment. Results of previous research showed that
intervention strategies that address the needs for information and material support of
African American older adults, can help improve adherence to cancer screening in this
population.
The purpose is to develop and evaluate model interventions to improve healthcare outcomes for
socially disadvantaged populations. The objective in this proposal is to conduct a randomized
controlled trial that evaluates the effects of an intervention that provides enhanced
education and material support, on adherence to care, among the cancer patients of the
Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.
The central hypothesis is that compared to the standard educational intervention delivered by
a registered nurse, the addition of an enhanced intervention (enhanced education,
problem-solving skills and facilitative support) will result in greater adherence care,
especially among patients with low health literacy.
communication approaches to patients with low health literacy. They have produced mixed
results in regard to implementation of successful interventions in addressing the needs of
this populations. Low health literacy is especially common in medically underserved
communities, including in North Philadelphia. Cancer treatment, including cancer
chemotherapy, is complex, and it requires substantial skills, in order for patients to adhere
to care and achieve the goals of therapy. Patients with low health literacy find it
especially challenging to navigate cancer treatment. Results of previous research showed that
intervention strategies that address the needs for information and material support of
African American older adults, can help improve adherence to cancer screening in this
population.
The purpose is to develop and evaluate model interventions to improve healthcare outcomes for
socially disadvantaged populations. The objective in this proposal is to conduct a randomized
controlled trial that evaluates the effects of an intervention that provides enhanced
education and material support, on adherence to care, among the cancer patients of the
Medical Oncology Clinic of the Einstein Medical Center in Philadelphia.
The central hypothesis is that compared to the standard educational intervention delivered by
a registered nurse, the addition of an enhanced intervention (enhanced education,
problem-solving skills and facilitative support) will result in greater adherence care,
especially among patients with low health literacy.
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
We found this trial at
1
site
Korman Research Pavilion%2c Suite 100
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
215-456-7215
Phone: 215-456-3880
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