Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma

Not Applicable

• Conditions: Multiple Myeloma
• Interventions: Behavioral: Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool; Behavioral: Standard of care consisting of standard counselling

• Registration Number: NCT04376957
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Study Timeline

• Study First Submitted: 2020-04-26
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Study Start: 2020-08-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counselled with MASCC Oral agent Teaching Tool (MOATT)	Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool	This group will receive counselling using the MASCC Oral Agent Teaching Tool and be compared with the standard of care counselling.
Counselled with Current Standard Care	Standard of care consisting of standard counselling	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 Outcome Measures

Name	Time	Method
Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.	18 months from study recruitment date.	Patient's preference and acceptability of using the MOATT intervention will be assessed using a 5 point Likert Scale after the intervention is completed. A higher score means a higher level of personal satisfaction and acceptance of the MOATT intervention.

Secondary Outcome Measures

Name	Time	Method
Objective adherence rate of medication assessed by number of cap openings.	18 months from study recruitment date.	All patients will be using the Medication Event Monitoring System (MEMS) pill cap and bottle which electronically records the date and time of the bottle opening to monitor adherence every month.
Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).	18 months from study recruitment date.	Brief Adherence Rating Scale (BARS) is a self-reported administered medication adherence assessment. It consists of three questions and an overall visual analog rating scale that will be administered every month.
Toxicities of Oral Myeloma Treatment assessed by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE tool).	18 months from study recruitment date.	PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. This will be administered every month.