Clinical trial · Interventional
Oncology - Bolstering Oral Agent Reporting Related to Distress
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral chemotherapy information and support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention plus usual care
- interventionNames
- Other: Oral chemotherapy information and support
- type
- NO_INTERVENTION
- label
- Usual care only
Primary outcomes (1)
- measure
- Feasibility and acceptability
- timeFrame
- Five months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhmed S, Maheu C, Gotlieb W, Batist G, Loiselle CG. Feasibility, Acceptability, and Potential Effects of a Digital Oral Anticancer Agent Intervention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 26;14:e55475. doi: 10.2196/55475. PMID 40138678