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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04376957
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hamilton Health Sciences Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hira Mian, MD
Principal Investigator Affiliation	Juravinski Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Additional Details

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.

Arms & Interventions

Arms

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).

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.

Interventions

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

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.

Behavioral: - Standard of care consisting of standard counselling

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Hira Mian, MD

hira.mian@medportal.ca

905-387-9495

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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