A Trial to Assess the Influence of a Pictorial Medication Calendar on Medication Taking Behaviour

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04701736

Collaborator

University of Waterloo (Other), Medbuy Corporation (Other), London Health Sciences Centre (Other)

Enrollment

Location

Arms

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine if an oncology pictorial medication calendar will improve patient adherence to oncology supportive care medication regimens for adult patients receiving adjuvant or neo-adjuvant chemotherapy treatment for cancer.

Condition or Disease	Intervention/Treatment	Phase
Cancer Chemotherapy Medication Adherence	Device: Picture Medication Calendar	N/A

Detailed Description

Primary Objective: In order to evaluate the impact of such an approach on adherence, a prospective, open-label, randomized controlled pilot trial (RCT) was carried out to determine if a picture-based medication calendar would improve patient adherence to antiemetic medication regimens for adult patients receiving chemotherapy treatment for solid organ tumor origins.

The secondary objectives were: 1) to assess medication use and self-efficacy parameters, 2) to determine patient comfort with antiemetic regimen prescribed along with chemotherapy and 3) to determine patient satisfaction with the calendar study tool.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Controlled Trial to Assess the Influence of a Picture-Based Antiemetic Medication Calendar on Medication-Taking Behavior in Adults Receiving Chemotherapy

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Routine Care Routine care consists of an oncology pharmacist counselling the patient on supportive care medications prior to the patient getting his or her prescription dispensed.
Active Comparator: Intervention The intervention group will encompass the oncology pharmacist using the computer system to print a Picture Medication Calendar for the patient and use the calendar to explain supportive medications, in addition to routine care.	Device: Picture Medication Calendar

Arm

Intervention/Treatment

No Intervention: Routine Care

Routine care consists of an oncology pharmacist counselling the patient on supportive care medications prior to the patient getting his or her prescription dispensed.

Active Comparator: Intervention

The intervention group will encompass the oncology pharmacist using the computer system to print a Picture Medication Calendar for the patient and use the calendar to explain supportive medications, in addition to routine care.

Device: Picture Medication Calendar

Outcome Measures

Primary Outcome Measures

Medication Adherence to Prescribed Antiemetics [1 year]
Adherence is quantified as the number of doses taken of a prescribed agent divided by the number of doses prescribed, expressed as a percentage. Pill counts were utilized to calculate the number of missed doses or pills taken as a percentage of the total number prescribed and dispensed.

Secondary Outcome Measures

Patient Understanding and Satisfaction Survey [1 year]
The participant survey conducted at end of study was investigator-created and asked questions regarding demographics and medication taking behaviors. Questions specifically related to the calendar for those in the intervention arm were also asked. Questions regarding satisfaction with the calendar as well as complexity of medication regimen for oncologic treatment were assessed using a 5-point Likert scale.
Medication Use and Self-Efficacy (MUSE) Scale [1 year]
19 The tool measures an individual's perceived ability to understand information about prescribed medicines, and to follow instructions for use.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Outpatients 18 years or older receiving chemotherapy treatment for neoadjuvant or adjuvant solid organ cancers,
Able to provide consent for themselves,
Calendar was only available in the English language, thus fluency in English was required.

Exclusion criteria:

Participants who did not attain a minimum of grade 8 education,
Significant visual impairment that precluded the ability to read the picture-based medication calendar,
Difficulty swallowing with requirement for liquid formulations of medications,
If planned to receive multiple cycles of chemotherapy at satellite oncology location instead of main study site,
If unable to repeat the instructions back to research personnel or a care provider had to speak on the participant's behalf, the participant was withdrawn from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9

Sponsors and Collaborators

Lawson Health Research Institute
University of Waterloo
Medbuy Corporation
London Health Sciences Centre

Investigators

Principal Investigator: Venita Harris, PharmD, London Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT04701736

Other Study ID Numbers:

107084

First Posted:

Jan 8, 2021

Last Update Posted:

Jan 8, 2021

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lawson Health Research Institute

patient adherence

chemotherapy

pictorial aid

complex medication regimen

cancer

Study Results

No Results Posted as of Jan 8, 2021