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

NCT03245411 | Recruiting DMC

• 2 other identifiers: 4950JT 27684
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Adherence to oral chemotherapy

  Frequency of missed chemotherapy doses post randomization (based on interviews)

  6 months

Secondary Outcomes (3)

• Frequency of medication refills

  6 months

• Adherence to scheduled follow-up medical care visits

  6 months

• Healthcare utilization

  6 months

Study Arms (2)

Standard of Care (Control Group)

NO INTERVENTION

All participants in this group will receive the standard of care intervention provided by the RN.

Intervention Group

EXPERIMENTAL

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.

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Claudia M Dourado, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia M Dourado, MD

CONTACT

215-456-3880; Douradoc@einstein.edu

Claudia Dourado

CONTACT

215-456-3880; Douradoc@einstein.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (RCT) Single Center

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 10, 2017
• Study Start: July 20, 2017
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)