160 Participants Needed

Oral Chemotherapy Adherence Program for Cancer

SA
BB
Overseen ByBethel Belayneh
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must be taking: Oral anticancer agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help people with cancer adhere to their oral chemotherapy treatments. The goal is to determine if the program makes it easier for patients to take their medication as prescribed, compared to standard care. Participants will be divided into two groups: one receiving standard care and the other receiving personalized counseling and support from pharmacists as part of a Multilevel Adherence Intervention. The trial seeks adults who have been taking oral cancer medication for at least six months for solid tumors or blood-related cancers. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could improve treatment adherence for future patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it seems you need to continue taking your oral anticancer medication, as the study focuses on adherence to these drugs.

What prior data suggests that this adherence program is safe for cancer patients?

Research shows that programs designed to help patients adhere to their oral cancer medication schedules are generally easy for patients to manage. These programs assist patients in following their medication regimens. Studies have found that such programs can reduce emergency room visits related to cancer and its treatment. For instance, one study found that patients receiving pharmacist-led care had fewer emergency visits compared to those without this support (9.5% vs. 13.7%).

Although detailed safety information about the program itself is limited, the focus remains on providing counseling and support, which are low-risk activities. The main goal is to ensure patients take their medications correctly, not to introduce new drugs. Therefore, this type of program presents no major safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve adherence to oral chemotherapy, a critical component of cancer treatment. Unlike the standard approach where patients receive general instructions, this program offers personalized counseling sessions with clinical pharmacists. This tailored support and continuous follow-up could lead to better adherence, potentially resulting in improved treatment outcomes and enhanced quality of life for patients.

What evidence suggests that this adherence program is effective for cancer patients?

Research has shown that adhering to oral chemotherapy schedules can greatly improve treatment success. In this trial, participants in the intervention arm will receive a structured adherence program, including individualized counseling sessions and tailored support. One study demonstrated that such programs increased patient adherence from 80% to 96.6%. Another study found that personalized support and regular check-ins led to better medication habits than standard care. These findings suggest that adherence programs can help patients follow their medication schedules more effectively, which is crucial for successful cancer treatment. Meanwhile, participants in the standard of care arm will receive education based on specific standards of procedure without additional tailored support.12467

Who Is on the Research Team?

BM

Benyam Muluneh, PharmD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors or blood cancers who have been on oral anticancer medications for at least six months. It's being conducted in various clinics, including academic, urban, and rural settings.

Inclusion Criteria

I have been diagnosed with cancer.
I have been on a single oral cancer drug for at least 6 months.
I am 21 years old or older.

Exclusion Criteria

Patients enrolled on hospice
I am on a treatment plan that is not continuous.
I am receiving care focused on comfort for end-of-life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Participants complete a survey and provide medication information prior to program enrollment

6 months

Post-implementation

Participants enrolled in the adherence program receive individualized counseling and are monitored for medication adherence

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Multilevel Adherence Intervention
Trial Overview The study tests a new program designed to help patients stick to their oral chemotherapy treatment plans. Participants are divided into two groups: one before the program starts and one after it's been running for six months, each surveyed about medication adherence.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention participantsExperimental Treatment1 Intervention
Group II: Standard of Care patientsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Interventions to Enhance Adherence to Oral Antineoplastic ...Adherence: Change from first to last visit, 80% to 96.6% (intervention); no change (83.4% at first and last visit) in ...
Implementation of an Oral Chemotherapy Adherence ...The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 ...
Investigating Oral Anticancer Medicine Adherence in AdultsThis overview of reviews aimed to identify and summarize available reviews of interventions to improve adherence to oral anticancer medicines in adult cancer ...
A randomized, controlled trial to assess a multi-level ...We hypothesize that compared to usual care, the addition of a multilevel intervention will result in greater adherence to oral cancer ...
Study Details | NCT03245411 | Assessment of Multi-Level ...Assessment of Multi-Level Interventions to Improve Adherence to Oral Medications in Cancer Patients. ClinicalTrials.gov ID NCT03245411.
Clinical Research Trial Listing ( Cancer ) ( NCT03245411 )The main objective is to study medication adherence to oral anticancer agents in patients with low literacy and poor socio-economic status.
Outcomes of pharmacist-led oral anticancer agent ...There was a decrease in cancer and treatment-related ED visits at 6 months in the pharmacist care compared to control group (9.5% vs 13.7%, p = ...
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