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

NCT04376957 | Unknown

• 1 other identifier: 9495
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.

  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.

  18 months from study recruitment date.

Secondary Outcomes (3)

• Objective adherence rate of medication assessed by number of cap openings.

  18 months from study recruitment date.

• Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).

  18 months from study recruitment date.

• 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.

Study Arms (2)

Counselled with Current Standard Care

ACTIVE COMPARATOR

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).

Behavioral: Standard of care consisting of standard counselling

Counselled with MASCC Oral agent Teaching Tool (MOATT)

EXPERIMENTAL

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

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

Interventions

Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool BEHAVIORAL

This tool was developed by an expert panel of oncology nurses and was further revised following external review of health care providers world-wide. This tools involves four key modules 1) patient's baseline knowledge, 2) patient education of oral cancer drugs 4) patient education tailored to a specific cancer drug 4) evaluation of the educational material. It was originally studied in 30 patients with lung cancer and was shown to be feasible with acceptable knowledge retention. Similarly, in a single center cohort study of general oncology patients, medication adherence self-efficacy appeared to improve with MOATT. The MOATT interventional tool incorporates key components of patient education and also has the advantage of being a potentially feasible tool that can be incorporated into future routine clinical practise.

Also known as: MOATT

Counselled with MASCC Oral agent Teaching Tool (MOATT)

Standard of care consisting of standard counselling BEHAVIORAL

Consists of instructions and information on the regimen, common side effects, symptom management, medication safety and how to contact a clinician for any problems encountered.

Counselled with Current Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hira Mian, MD

  Juravinski Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Mian, MD

CONTACT

905-387-9495; hira.mian@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist, Juravinski Cancer Center Assistant Professor, Department of Oncology, McMaster University

Model Details: 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).

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 6, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share