Oncology - Bolstering Oral Agent Reporting Related to Distress

Not Applicable

Completed

• Conditions: Oral Chemotherapy
• Interventions: Other: Oral chemotherapy information and support

• Registration Number: NCT04984850
• Lead Sponsor: McGill University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-02
• Study Start: 2022-01-07
• Primary Completion: 2023-12-30
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention plus usual care	Oral chemotherapy information and support	-

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability	Five months	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.

Secondary Outcome Measures

Name	Time	Method
Potential effects of intervention via medication adherence self-efficacy, medication adherence and symptom distress	Five months	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.

Trial Locations

Locations (1)

CIUSSS du Centre-Ouest-de-l'Île-de-Montréal; 🇨🇦 Montréal, Quebec, Canada