- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376957
Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hira Mian, MD
- Phone Number: 905-387-9495
- Email: hira.mian@medportal.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Counselled with Current Standard Care
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).
|
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.
|
Experimental: Counselled with MASCC Oral agent Teaching Tool (MOATT)
This group will receive counselling using the MASCC Oral Agent Teaching Tool and be compared with the standard of care counselling.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Personal Patient Preference Towards Using the MOATT Intervention assessed by a 5 point Likert scale.
Time Frame: 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.
|
18 months from study recruitment date.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective adherence rate of medication assessed by number of cap openings.
Time Frame: 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.
|
18 months from study recruitment date.
|
Self Reported Adherence Rate assessed by Brief Adherence Rating Scale (BARS).
Time Frame: 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.
|
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).
Time Frame: 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.
|
18 months from study recruitment date.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hira Mian, MD, Juravinski Cancer Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 9495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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