Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool
Standard of care consisting of standard counselling
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Counselled with Current Standard Care
Counselled with MASCC Oral agent Teaching Tool (MOATT)
Arm 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).
This group will receive counselling using the MASCC Oral Agent Teaching Tool and be compared with the standard of care counselling.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective adherence rate of medication assessed by number of cap openings.
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).
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).
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.
Full Information
NCT ID
NCT04376957
First Posted
April 26, 2020
Last Updated
May 5, 2020
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04376957
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Counselled with Current Standard Care
Arm Type
Active Comparator
Arm 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).
Arm Title
Counselled with MASCC Oral agent Teaching Tool (MOATT)
Arm Type
Experimental
Arm Description
This group will receive counselling using the MASCC Oral Agent Teaching Tool and be compared with the standard of care counselling.
Intervention Type
Behavioral
Intervention Name(s)
Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool
Other Intervention Name(s)
MOATT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care consisting of standard counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.
Description
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.
Time Frame
18 months from study recruitment date.
Secondary Outcome Measure Information:
Title
Objective adherence rate of medication assessed by number of cap openings.
Description
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.
Time Frame
18 months from study recruitment date.
Title
Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).
Description
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.
Time Frame
18 months from study recruitment date.
Title
Toxicities of Oral Myeloma Treatment assessed by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE tool).
Description
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.
Time Frame
18 months from study recruitment date.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hira Mian, MD
Phone
905-387-9495
Email
hira.mian@medportal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Mian, MD
Organizational Affiliation
Juravinski Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
We'll reach out to this number within 24 hrs