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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701736
• Other study ID #: 107084
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: December 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Chemotherapy
• Medication Adherence

Intervention

Device:
• Picture Medication Calendar

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	London Health Sciences Centre, Medbuy Corporation, University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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