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NCT Number: NCT03245411

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence to oral chemotherapy

    Time frame: 6 months

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

Secondary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Dourado

CONTACT

[email protected]

215-456-3880

Claudia M Dourado, MD

CONTACT

[email protected]

215-456-3880

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Randomized, Controlled Trial to Assess Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients in a Socioeconomically Disadvantaged Community

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2017
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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