Oncology - Bolstering Oral Agent Reporting Related to Distress (ON-BOARD)

Feasibility, Acceptability, and Potential Effects of a Comprehensive Oral Chemotherapy Intervention on Medication Adherence Self-efficacy, Medication Adherence, and Symptom Distress: A Pilot Randomized Control Trial

Individuals on oral chemotherapy (OC) often face many challenges requiring adequate informational support, monitoring, and management. This pilot randomized control trial (RCT) aims to assess the feasibility, acceptability, and preliminary effects of a comprehensive OC intervention on medication adherence self-efficacy, medication adherence, and symptom distress.

Study Overview

• Status: Completed
• Conditions: Oral Chemotherapy
• Intervention / Treatment: Other: Oral chemotherapy information and support

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3A1L4
      • CIUSSS du Centre-Ouest-de-l'Île-de-Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• Diagnosis of cancer, any stage
• Being followed by a care team at the affiliated hospital centre
• About to start or within the first cycle of oral anticancer treatment (traditional cytotoxic, targeted therapy, hormonal therapy as active ongoing treatment for cancer with the aim of killing cancer cells/shrinking tumor size)
• Has a computer/tablet/smartphone device with internet
• The ability to communicate, read, and write in English or French

Exclusion Criteria:

• Receiving IV chemotherapy, immunotherapy, and/or oral hormonal therapy as long-term maintenance treatment for prevention of cancer's return/growth of cancer cells after initial treatment
• Significant physical or cognitive limitations that would prevent ability to participate in study as reported by patient, primary healthcare provider, or research staff
• At imminent "end-of-life"
• Participating in an ongoing clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention plus usual care	Other: Oral chemotherapy information and support; Multimodal intervention : (1) handouts and videos presenting information and supportive resources for common oral chemotherapy related issues, (2) phone call(s) from a nurse in oncology, and (3) e-reminders to take medication. The intervention will be available to experimental group participants on mobile platform.
No Intervention: Usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability	Study feasibility assessed by the recruitment rate (percentage, dividing the total number of participants recruited throughout the study by the number of months recruitment occurred), retention rate (percentage, comparing the number of participants who complete baseline e-questionnaires to the number of participants who complete study exit e-questionnaires), response rate to study e-questionnaires (percentage, the number of completed follow-up e-questionnaire assessments for participants who complete the study), and uptake of intervention (percentage, calculated by comparing by number of participants who actually access the intervention to the total number who are given access). Intervention acceptability assessed by intervention burden, intervention coherence, and perceived effectiveness using the Tariman et al. (2011) Acceptability e-scale for web-based patient-reported outcomes in cancer care. Mean scores range from 1 to 5, higher score indicating higher acceptability.	Five months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential effects of intervention via medication adherence self-efficacy, medication adherence and symptom distress	Medication adherence self-efficacy by the Medication Adherence Self-Efficacy Scale (MASES) (Ogedegbe et al., 2003). Total scores range from 20 to 60, higher scores indicating higher medication adherence self-efficacy. Medication adherence via Proportion of Days Covered (PDC), percentage representing the sum of the days' supply of a given drug divided by the number of days in the time period. Higher percentage indicating higher medication adherence. Medication adherence self-report via the Medication Adherence Report Scale (MARS-5, Professor Rob Horne; Chan et al., 2020). Total scores range from 5 to 25, higher score indicating higher self-reported adherence. Physical and psychosocial symptom distress measured via Edmonton Symptom Assessment Scale Revised (ESAS-r) for anxiety, depression, drowsiness, fatigue, fear of cancer recurrence, lack of appetite, nausea, shortness of breath, sleep, wellbeing, and work. Each is rated from 0 to 10, 0 being none and 10 being the worst possible.	Five months

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Rossy Cancer Network

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: medication adherence; self-efficacy; Oral chemotherapy; pilot randomized control trial
• Other Study ID Numbers: 2021-2861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No