Oncology - Bolstering Oral Agent Reporting Related to Distress

NCT04984850 | Completed

• 1 other identifier: 2021-2861
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Chemotherapy

Keywords

Oral chemotherapy; medication adherence; self-efficacy; pilot randomized control trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Potential effects of intervention via medication adherence self-efficacy, medication adherence and symptom distress

  Five months

Study Arms (2)

Intervention plus usual care

EXPERIMENTAL

Other: Oral chemotherapy information and support

Usual care only

NO INTERVENTION

Interventions

Oral chemotherapy information and support OTHER

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.

Intervention plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Rossy Cancer Network: collaborator

Study Sites (1)

CIUSSS du Centre-Ouest-de-l'Île-de-Montréal

Montreal, Quebec, H3A1L4, Canada

Location

Related Publications (1)

• Ahmed 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 DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Following baseline, participants randomized immediately to receive either the intervention plus usual care (experimental group, n = 26) or usual care only (control group, n = 26).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: August 2, 2021
• Study Start: January 7, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)