Clinical trial NCT03245411: Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients
Official title: A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-08-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT) Single Center
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Adherence to oral chemotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of medication refills
timeFrame: 6 months
measure: Adherence to scheduled follow-up medical care visits
timeFrame: 6 months
measure: Healthcare utilization
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Claudia M Dourado, MD
role: PRINCIPAL_INVESTIGATOR
References: