search
Back to results

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
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

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

    First Posted
    April 26, 2020
    Last Updated
    May 5, 2020
    Sponsor
    Hamilton Health Sciences Corporation
    search

    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