NCT04701736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

August 25, 2017

Last Update Submit

January 6, 2021

Conditions

Keywords

patient adherencechemotherapypictorial aidcomplex medication regimencancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient Understanding and Satisfaction Survey

    1 year

  • Medication Use and Self-Efficacy (MUSE) Scale

    1 year

Study Arms (2)

Routine Care

NO INTERVENTION

Routine care consists of an oncology pharmacist counselling the patient on supportive care medications prior to the patient getting his or her prescription dispensed.

Intervention

ACTIVE COMPARATOR

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

Interventions

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

NeoplasmsMedication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Venita Harris, PharmD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

January 8, 2021

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 8, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations