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Clinical Trials/NCT02468245
NCT02468245UnknownNot Applicable

Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?

Bassett Healthcare1 site in 1 country60 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Oral chemotherapy compliance

Study Overview

Brief Summary

This study is being conducted by Bassett Healthcare Network in coordination with Bassett Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider consent to this study. This study will try to establish if nursing interventions can help improve patients' adherence to taking their oral chemotherapies as prescribed by their doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer diagnoses. Adherence to the prescribed treatment plan is very important to gain the best response to these types of treatments. The study will examine if nursing intervention via weekly phone calls may help improve adherence to oral chemotherapy treatment plans.

Detailed Description

The purpose of this study is to investigate which nursing intervention will help to improve adherence in adult patients who are receiving oral chemotherapy. This study will identify the barriers to adherence, interventions that will increase patients' adherence, and the role of nursing in promoting oral chemotherapy adherence. Oral chemotherapy adherence is important in the setting of cancer care as many new chemotherapy medications being approved for use are oral chemotherapies. Nursing responsibility in this study is to help promote interventions that would improve adherence. The literature shows that the best intervention to promote adherence to oral chemotherapy is education that patients receive prior to them starting their treatment. The interventions such as the MEMS system, AVR, and the generic diary were studied and found to be somewhat effective in improving adherence, but not reliable. The literature supports the use of individualized and personalized education for patients. The education should be in terms that they can understand and absorb, and it should be information that they need related to their treatment.

Oral chemotherapy has emerged as the growing treatment of choice in the cancer treatment specialty; accounting for a quarter of the 400 anticancer medications currently under development (Simchowitz et al., 2010). There are now more than 20 oral antineoplastic agents approved for use in the United States alone; and dozens more under development (Ruddy, Mayer, & Partridge, 2009). Chemotherapy treatments are moving in the direction of conveniences for patients. Oral chemotherapies can be given to patients to take home and be administered in the convenience of their homes. This process works for some patients, but not all.

One of the biggest issues that health care providers find with oral chemotherapy is the non-adherence with the regimens. Without nursing education and follow up interventions, adherence is even more difficult to obtain. Although some patients want to experience having the same care and intervention as a patient receiving intravenous chemotherapy, the mindset of receiving oral chemotherapy is that it is just a pill and not taken seriously by some patients. In a study conducted at Dana Farber, most patients would prefer oral chemotherapy to intravenous (IV) chemotherapy for its convenience, ease of use, and painless administration (Simchowitz et al., 2010). Although most patients realize the importance of taking their medication and adhering to the regimen, they are still non-adherent and suffer unneeded side effects due to that non-adherence. Not to mention that they do not get the full therapeutic effect of the oral chemotherapy regimen.

The standard process for treatment with oral chemotherapy agents start with the providers request for the agent via prescription. Once patient has received approval and has the drug available, the patient will call the cancer center to set up a formal educational appointment with an oncology certified chemotherapy nurse (OCN). The OCN meets with the patient to review potential side effects, how to manage those side effects, and how to properly take the oral chemotherapy. It will be at this education appointment that, the patient will be approached for interest in the study.

Subjects will be identified as any patient that has an oral chemotherapy prescribed that meets the inclusion criteria (please see inclusion/exclusion criteria list later in this document). If the patient expresses interest informed consent process will begin.Once patient has given informed consent, the OCN will confirm eligibility. Once consented and eligibility verified, they will be randomized to either the control group (no intervention, standard of care [SOC]) or to the study group (the intervention group). The initial sample size is 60. All eligible patients' prescribed oral chemotherapy will be approached until sample size of 60 participants has been reached. An interim analysis will be completed after 60 patients have completed the study to assess adequacy of the sample size.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Must be >= 18 years of age
  • •Have a diagnosis of Cancer that will require an oral chemotherapy
  • •Be treated at Bassett Medical Center Cancer Center
  • •Must not be receiving radiation or infusional chemotherapy concomitantly with their oral chemotherapy

Exclusion Criteria

  • •Being treated at satellite sites
  • •Receiving radiation and/or infusional chemotherapy concurrently with oral chemotherapy
  • •Due to impairment or other reasons, patient unable to provide consent or comply with survey.

Arms & Interventions

Control Arm

Active Comparator

This is a "usual care" group. Patients in this arm will receive the standard pre-drug initiation training and 4 week clinic follow up visit.

Intervention: usual care (Behavioral)

Intervention arm

Experimental

Patients in this arm will also receive the standard pre-drug initiation training followed by telephone follow up by an oncology certified chemotherapy nurse (OCN) at week one, two, and three. Patients will then have the standard 4 week follow up clinic visit.

Intervention: weekly telephone follow up (Behavioral)

Outcomes

Primary Outcomes

Oral chemotherapy compliance

Time Frame: 4 weeks

A 4 week pill count will be completed on all participants to measure drug compliance.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kelly Morris, RN

Nurse Manager

Bassett Healthcare

Study Sites (1)

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