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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245411
• Other study ID #: 4950 EXP
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: December 20, 2022

Study information

• Verified date: December 2021
• Source: Albert Einstein Healthcare Network
• Contact: Claudia M Dourado, MD
• Phone: 215-456-3880
• Email: Douradoc[@]einstein.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Intervention
All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.

Locations

Country	Name	City	State
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to oral chemotherapy	Frequency of missed chemotherapy doses post randomization (based on interviews)	6 months
Secondary	Frequency of medication refills	Prescription refills, based on pharmacy records	6 months
Secondary	Adherence to scheduled follow-up medical care visits	Frequency and adherence to schedule follow up visit	6 months
Secondary	Healthcare utilization	Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)	6 months