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

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ClinicalTrials.gov Identifier: NCT03245411
Recruitment Status : Active, not recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jean Ford, 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.


Study Type : Interventional  (Clinical Trial)
Actual 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 : January 20, 2018
Estimated Study Completion Date : July 20, 2019

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)



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

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 ClinicalTrials.gov identifier (NCT number): NCT03245411


Locations
United States, Pennsylvania
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jean G Ford, MD Albert Einstein Healthcare Network

Responsible Party: Jean Ford, MD, Principal Investigator, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT03245411     History of Changes
Other Study ID Numbers: 4950 EXP
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No