Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients

Not Applicable

• Conditions: Cancer
• Interventions: Behavioral: Intervention

• Registration Number: NCT03245411
• Lead Sponsor: Albert Einstein Healthcare Network

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.

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention	In addition to the standard of care, the participants randomized to Intervention Group will be invited to a separate room. The following activities will be undertaken, in order to address patients' questions and concerns, and discuss potential solutions to their barriers to care The patient will be asked to watch brief educational videos on "Life with oral cancer treatment." The information contained in the videos will be reinforced with materials written at a 4th grade level, that correspond to each of the brief videos.The patient will receive a brief phone call (from the study coordinator) on the first business day following the baseline interview, and thereafter, two weeks following each visit to the oncology clinic.

Primary Outcome Measures

Name	Time	Method
Adherence to oral chemotherapy	6 months	Frequency of missed chemotherapy doses post randomization (based on interviews)

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization	6 months	Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)
Frequency of medication refills	6 months	Prescription refills, based on pharmacy records
Adherence to scheduled follow-up medical care visits	6 months	Frequency and adherence to schedule follow up visit

Trial Locations

Locations (1)

Albert Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States