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

Hamilton Health Sciences (HHS)

Status: Unknown

Conditions: Multiple Myeloma

Treatments: Behavioral: Standard of care consisting of standard counselling; Behavioral: Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04376957

9495

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Counselled with Current Standard Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard of care consisting of standard counselling

Counselled with MASCC Oral agent Teaching Tool (MOATT)

Experimental group

Description:

This group will receive counselling using the MASCC Oral Agent Teaching Tool and be compared with the standard of care counselling.

Treatment:

Behavioral: Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool