Oral Adherence in Adults with Acute Myeloid Leukemia: Results of a Mixed Methods Study
Authors: Bryant Ashley Leak , LeBlanc Thomas W. , Albrecht Tara , Chan Ya-Ning , Richardson Jaime , Foster Matthew C , Malisa Dang , Owenby Susie , Wujcik Debra 
Published: November 2019

BACKGROUND: The incidence of AML is increasing, in part due to the overall aging population; median age at presentation is 67 years. Overall 5-year survival rates are as low as 5%-10% in adults >60 years (Wang, 2014). While standard treatment for AML is intravenous chemotherapy, the availability of oral medication (OM) has increased in recent years, providing significant benefits to patients, along with new tradeoffs and risks. This means the burden of daily adherence has shifted from the provider to the patient. A 2016 systematic review of 63 adherence studies found that as few as 46% of patients take the prescribed dose on the correct schedule (Greer et al, 2016). A clear understanding of barriers to adherence with OM in the AML population is critically important. We sought to identify and summarize adherence for OM as described by patients with AML.
METHODS: This was a mixed methods study design using focus groups and patient surveys. Focus groups were conducted with four individual groups. 11 patients (5 <65 years; 6 >65 years) and 4 caregivers participated. All sessions were digitally recorded, and files were transcribed verbatim by a professional service. Focus groups results were used to develop a 37-item OM adherence needs assessment. The survey allowed patients to list barriers to oral adherence and side effects from OM. AML patients were recruited and consented at three cancer centers. Surveys were completed online at either the clinic or from home.
RESULTS: 100 patients completed the OM survey and were mostly male (62%), white (67%), less than 65 years of age (59%), and college educated (52%). Overall, there were no significant differences found between the older (>65 years) and younger age groups. The most frequent and troublesome challenge in taking OM is the number of pills (54%). Loss of appetite (55%) and nausea (40%) were the most commonly reported side effects of OM and loss of appetite is the most problematic (35%). Although half of the patients said no side effect would cause them to stop taking OM, another 25% indicated nausea would cause them to stop taking them. When asked what has been used to support taking OM, the most commonly cited strategy was to make it part of the daily routine. Patients felt information from the health care team was the best source of directions for taking medication. Nearly a third of patients indicated that they skip the medication altogether when they forget to take it. When asked what would help them to adhere to taking their OM as prescribed, smaller pills, easier packaging, and assistance with scheduling were most frequently selected. 12 questions on attitudes (pros and cons) towards taking OM were answered on a 1 to 4 response scale with and 1 = "Strongly Disagree" and 4 = "Strongly Agree". The means for each question ranged from 1.11 to 3.25 and the mean for all 12 items was 2.45, SD=.40. Age group differences showed older individuals had a slightly higher score indicating a more positive attitude towards OM t(94) =.67, p =.51. Attitudes towards IV vs OM were assessed using 9 Likert style questions with responses ranging from 1 - 5 with 1= "Disagree Strongly" and 5 = "Agree Strongly". Mean scores for each question ranged from 1.67 to 5.00 and the mean for all 9 items was 3.32, SD=.58. Younger patients were more accepting of taking Oral vs IV meds. Adherence challenges were number and size of pills, different directions, cost, availability, and side effects. An adherence plan was recommended to include written schedules, taking medications around meals, and use of pillboxes and alarms. Main sources of information were the health care team and medication bottle directions. Recommendations for providing adherence assistance included better instructions, assistance with scheduling, making pills smaller, and consistency in packaging.
CONCLUSION: This project represents the first assessment of OM adherence in patients with AML. Three themes emerged in focus group transcript analysis that informed the development of a 37-item survey. Several implications for clinicians and OM manufacturers were identified. Findings provide the basis for further exploration of interventions to enhance and increase adherence to OM regimens, which could include symptom monitoring and/or a medication management tool to address incorporating OM into the patient's daily routine.

Disclosures
LeBlanc: Duke University: Research Funding; American Cancer Society: Research Funding; Helsinn: Consultancy; Pfizer Inc: Consultancy; Flatiron: Consultancy; Seattle Genetics: Consultancy, Research Funding; Celgene: Honoraria; Medtronic: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Heron: Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; CareVive: Consultancy; NINR/NIH: Research Funding; Jazz Pharmaceuticals: Research Funding; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Consultancy, Research Funding. Albrecht:Oncology Nursing Society: Honoraria; Cancer Support Community: Membership on an entity's Board of Directors or advisory committees; Carevive: Research Funding. Foster:Bellicum Pharmaceuticals, Inc: Research Funding; Daiichi Sankyo: Consultancy; MacroGenics: Research Funding; Celgene: Research Funding.