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

NCT ID: NCT04701736

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Cancer; Chemotherapy; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Picture Medication Calendar

Intervention Type: DEVICE

Interventions

Picture Medication Calendar

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

Medbuy Corporation

UNKNOWN

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Venita Harris, PharmD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

107084

Identifier Type: -

Identifier Source: org_study_id