Recruiting

Medication Adherence

Sponsor:

Thomas Jefferson University

Code:

NCT03245411

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention

Study Details

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

Study ID

NCT03245411

Start date

Jul 20, 2017

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Adherence to oral chemotherapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Claudia M Dourado, MD

215-456-3880Douradoc@einstein.edu

Claudia Dourado

215-456-3880Douradoc@einstein.edu

Locations

Albert Einstein Healthcare Network

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Claudia M Claudia M Dourado, MD

215-456-3880DouradoC@einstein.edu

John C Leighton, MD

215-456-3880leightoj@einstein.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-05-29.