Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03245411
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : December 8, 2021
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Claudia Dourado,MD, 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial (RCT) Single Center
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
No Intervention: Standard of Care (Control Group)
All participants in this group will receive the standard of care intervention provided by the RN.
Experimental: Intervention Group

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
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.

Primary Outcome Measures :
  1. Adherence to oral chemotherapy [ Time Frame: 6 months ]
    Frequency of missed chemotherapy doses post randomization (based on interviews)

Secondary Outcome Measures :
  1. Frequency of medication refills [ Time Frame: 6 months ]
    Prescription refills, based on pharmacy records

  2. Adherence to scheduled follow-up medical care visits [ Time Frame: 6 months ]
    Frequency and adherence to schedule follow up visit

  3. Healthcare utilization [ Time Frame: 6 months ]
    Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03245411

Layout table for location contacts
Contact: Claudia M Dourado, MD 215-456-3880
Contact: Claudia Dourado 215-456-3880

Layout table for location information
United States, Pennsylvania
Albert Einstein Healthcare Network Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Claudia M Claudia M Dourado, MD    215-456-3880   
Contact: John C Leighton, MD    215-456-3880   
Sponsors and Collaborators
Albert Einstein Healthcare Network
Merck Sharp & Dohme LLC
Layout table for investigator information
Principal Investigator: Claudia M Dourado, MD Albert Einstein Healthcare Network
Layout table for additonal information
Responsible Party: Claudia Dourado,MD, Clinical Assistant Professor of Medicine, Albert Einstein Healthcare Network Identifier: NCT03245411    
Other Study ID Numbers: 4950 EXP
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No