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Completed

NCT Number: NCT04701736

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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back to research personnel or a care provider had to speak on the participant's behalf, the participant was withdrawn from the study.

Treatment and study plan

Picture Medication Calendar

Device

Primary outcomes

  1. Medication Adherence to Prescribed Antiemetics

    Time frame: 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 outcomes

  1. Patient Understanding and Satisfaction Survey

    Time frame: 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.

  2. Medication Use and Self-Efficacy (MUSE) Scale

    Time frame: 1 year

    19 The tool measures an individual's perceived ability to understand information about prescribed medicines, and to follow instructions for use.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • London Health Sciences Centre
  • Medbuy Corporation
  • University of Waterloo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2021
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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