Oncology - Bolstering Oral Agent Reporting Related to Distress

NCT ID: NCT04984850

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2024-01-30

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.

Detailed Description

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Conditions

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Oral Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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).

Study Groups

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Intervention plus usual care

Group Type EXPERIMENTAL

Oral chemotherapy information and support

Intervention Type 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.

Usual care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rossy Cancer Network

UNKNOWN

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role lead

Responsible Party

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Carmen G. Loiselle, N., Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40138678 (View on PubMed)

Other Identifiers

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2021-2861

Identifier Type: -

Identifier Source: org_study_id

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