Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02468245 |
| Other study ID # |
1096 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Bassett Healthcare |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
If randomized to the study arm, the OCN will follow-up with that patient at week one, two,
three via phone,. At week four, follow-up will occur at the patients routinely scheduled
medical oncology visit. For the control group, data will be collected at initial education
visit and again at the 4 week physician visit. At the initial education visit both the study
group and the control group will receive the standard chemotherapy education, and complete a
QOL questionnaire. For the study group, at the initial education visit, a time for each phone
call that is convenient for the patient will be scheduled. At each phone call, the OCN will
get a pill count and discuss reasons for missed doses if applicable; grade any adverse events
(AE's) experienced and interventions for those side effects; and answer any questions or
concerns that they patient may be having.
The control group will not receive contact by the OCN at week 1, 2 and 3. At week four, both
the control group and the study group will have a complete physical, pill count, QOL
completion and document any AE experienced.
The quality of life (QOL) survey tool will be a questionnaire that is self-reported by the
patient. This will be done at the initial education session and again at the four week follow
up session, for both the control and the intervention group. The sample size will be 60
participants, 30 for the control group and 30 for the intervention group.
