Clinical trial NCT04376957: Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
Official title: Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to standard of care counselling done for oral myeloma medications or will be counselled using the novel teaching tool MASCC Oral agent Teaching Tool (MOATT). Standard of care consists of standard counselling and written materials provided by the oncologist or pharmacy (e.g. instructions and information on the regimen, common side effects, symptom management, medication safety and how to contact a clinician for any problems encountered).
Primary purpose: TREATMENT

Brief summary: Multiple Myeloma is an incurable cancer. Therapies for it include oral chemotherapy pills. It is unknown whether patients regularly and correctly take these anti-myeloma pills. This study wants to measure the rate of adults with MM taking anti-myeloma pills correctly. The investigators also want to use a teaching tool to see if it will help patients feel more satisfied and more confident in taking their anti-myeloma pills correctly. The investigators hope to use this data from this small study to eventually do a larger study in this area.

Detailed description: The prevalence of patients with myeloma utilizing orally-administered myeloma therapy (OMT) is expected to continuously rise within Canada. The MASCC Oral agent Teaching Tool (MOATT) interventional tool relies on the concept of improved patient education in turn leading to improved adherence. Although the MOATT intervention is currently endorsed by Cancer Care Ontario, there is no data using the MOATT intervention in patients with myeloma or within Canada. Prior to embarking on a larger, multi-center study, a pilot study is necessary to 1) understand the feasibility, acceptability of the MOATT intervention and its preliminary efficacy 2) to determine the rates of adherence to OMT and explore factors associated with non-adherence and 3) to determine the feasibility of a larger multi-centre trial.

Eligibility criteria: Inclusion Criteria:

* Will include adults (age\>18) with multiple myeloma who will be initiating OMT (lenalidomide or pomalidomide in the next 6 months) for either newly diagnosed, maintenance-phase or relapsed myeloma at the JCC

Exclusion Criteria:

* Patients who reside in a facility in which their medications are administered to them (such as a nursing home)

Primary outcomes:
measure: Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.
timeFrame: 18 months from study recruitment date.
Secondary outcomes:
measure: Objective adherence rate of medication assessed by number of cap openings.
timeFrame: 18 months from study recruitment date.
measure: Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).
timeFrame: 18 months from study recruitment date.
measure: Toxicities of Oral Myeloma Treatment assessed by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE tool).
timeFrame: 18 months from study recruitment date.
Other outcomes:
Locations:
Study officials:
affiliation: Juravinski Cancer Center
name: Hira Mian, MD
role: PRINCIPAL_INVESTIGATOR
References: