Oncology - Bolstering Oral Agent Reporting Related to Distress

Oral Chemotherapy Clinical Trial

— ON-BOARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984850
• Other study ID #: 2021-2861
• Status: Completed
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Chemotherapy

Intervention

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.

Locations

Country	Name	City	State
Canada	CIUSSS du Centre-Ouest-de-l'Île-de-Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Rossy Cancer Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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