Combining proactive medication assessment and electronic monitoring for oral cancer therapy

Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

This study is testing if using electronic monitoring and regular check-ins can help improve the care and quality of life for patients undergoing treatment for oral cancer by better tracking side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 6 sites (Brive-la-Gaillarde and 5 other locations)
• Trial ID: NCT05345587 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of proactive medication assessment and electronic monitoring of toxicities in patients undergoing oral cancer therapy. It aims to address the challenges of outpatient care, including drug interactions and the relationship between community healthcare providers and hospitals. By using electronic monitoring, the study seeks to improve the detection of side effects and enhance the quality of life for patients receiving oral cancer treatments. The approach focuses on capturing patient-reported outcomes to better manage treatment-related toxicities.

Who should consider this trial

Good fit: Ideal candidates are patients starting oral therapy for metastatic or locally advanced cancer who can use connected electronic devices.

Not a fit: Patients who are illiterate, pregnant, or have serious uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of side effects and enhanced quality of life for patients undergoing oral cancer therapy.

How similar studies have performed: Other studies have shown promise in using electronic monitoring for managing cancer treatment side effects, indicating that this approach has potential for success.

Eligibility criteria

Inclusion Criteria:

* Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
* Patient able to use a connected electronic object
* Patient with a smartphone/tablet or computer with internet access and an email address.
* Patient with WHO status ≤2
* Patients receiving other cancer therapy concurrently with oral therapy may be included
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant, parturient or breast feeding
* Illiterate patient
* Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
* Patient receiving hormone therapy alone for breast or prostate cancer

Where this trial is running

Brive-la-Gaillarde and 5 other locations

• Centre Hospitalier Dubois Brive — Brive-la-Gaillarde, France (Recruiting)
• Chic Castres-Mazamet — Castres, France (Recruiting)
• Centre Hospitalier Emile ROUX — Le Puy-en-Velay, France (Recruiting)
• CHU de Nîmes — Nîmes, France (Recruiting)
• Institut cancerologie du Gard — Nîmes, France (Recruiting)
• Médipôle Lyon-Villeurbanne — Villeurbanne, France (Recruiting)

Study contacts

• Principal investigator: Frédéric Fiteni — CHU de Nimes
• Study coordinator: Frédéric Fiteni

Conditions Cancer