Oncology - Bolstering Oral Agent Reporting Related to Distress

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Oral Chemotherapy

Intervention / Treatment
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* Other: Oral chemotherapy information and support


Participation Criteria
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Eligibility Criteria
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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 chemotherapy treatment 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 targeted therapy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention plus usual care<br> | Other: Oral chemotherapy information and support<br>* 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.<br>|
| No Intervention: Usual care only<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence self-efficacy | Measured with the Medication Adherence Self-Efficacy Scale (MASES) was developed by Ogedge et al. (2003), evaluates the confidence of patients to take their medication. | Five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence and symptom distress | Medication Adherence Self-Efficacy Scale (MASES) was developed by Ogedge et al. (2003). It evaluates the confidence of patients to take their medication. The scale has a Cronbach alpha of 0.95 and contains 25 items, each are rated from 1 (not at all sure) to 3 (extremely sure), a total score calculated by summing the responses. The scale initially developed within the context of anti-hypertensive medications has been previously modified and adapted for oncology oral agents with 24 items. For the current study, the oral agent scale was further modified with 20 items to be used. | Five months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral chemotherapy, medication adherence, self-efficacy, pilot randomized control trial