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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Chemotherapy; Medication Adherence
• Intervention / Treatment: Device: Picture Medication Calendar

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence to Prescribed Antiemetics	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Understanding and Satisfaction Survey	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.	1 year
Medication Use and Self-Efficacy (MUSE) Scale	19 The tool measures an individual's perceived ability to understand information about prescribed medicines, and to follow instructions for use.	1 year

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: London Health Sciences Centre; University of Waterloo; Medbuy Corporation
• Investigators: Principal Investigator: Venita Harris, PharmD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: chemotherapy; cancer; patient adherence; pictorial aid; complex medication regimen
• Other Study ID Numbers: 107084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No