Clinical trial NCT04701736: A Trial to Assess the Influence of a Pictorial Medication Calendar on Medication Taking Behaviour
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy
Medication Adherence
Keywords: patient adherence
chemotherapy
pictorial aid
complex medication regimen
cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Waterloo
name: Medbuy Corporation
name: London Health Sciences Centre
First posted: 2021-01-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence to Prescribed Antiemetics
timeFrame: 1 year
Secondary outcomes:
measure: Patient Understanding and Satisfaction Survey
timeFrame: 1 year
measure: Medication Use and Self-Efficacy (MUSE) Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Venita Harris, PharmD
role: PRINCIPAL_INVESTIGATOR
References: