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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Chemotherapy, Medication Adherence

Intervention / Treatment
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* Device: Picture Medication Calendar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>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<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, patient adherence, chemotherapy, pictorial aid, complex medication regimen