Health TrialsbyHealthPanel

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

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

ECOG Performance Status of 3 and above

Concurrent chemo radiation

Non-English speaker

Clinical diagnosis of dementia, or otherwise unable to give informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Standard of Care (Control Group)No intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adherence to oral chemotherapy

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

Time frame
6 months

Secondary outcomes

1

Frequency of medication refills

Prescription refills, based on pharmacy records

Time frame
6 months
2

Adherence to scheduled follow-up medical care visits

Frequency and adherence to schedule follow up visit

Time frame
6 months
3

Healthcare utilization

Any unscheduled visit (office Visit, ED Visits, Hospitalization, use of preventive care)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
Apply now