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

Overview

Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital. Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient. Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally. Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.

Interventions

• Other THESS monitoring
  Consultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days

Primary outcome measures

• Time until decrease in quality of life by 5-points between groups [Time frame: End of follow-up maximum 18 months]

Secondary outcome measures (12)

• Time until progression of cancer between groups [Time frame: End of follow-up maximum 18 months]
• Patient satisfaction with their treatment between groups [Time frame: 3 months]
• Patient satisfaction with their treatment between groups [Time frame: 6 months]
• Patient satisfaction with their treatment between groups [Time frame: 9 months]
• Patient satisfaction with their treatment between groups [Time frame: 12 months]
• Patient satisfaction with their treatment between groups [Time frame: 15 months]
• Patient satisfaction with their treatment between groups [Time frame: 18 months]
• Quality of life adjusted years between groups [Time frame: 18 months]
• Cost of care between groups [Time frame: End of study (18 months)]
• Toxicity experienced during treatment between groups [Time frame: 3 months]
• Toxicity experienced during treatment between groups [Time frame: 6 months]
• Toxicity experienced during treatment between groups [Time frame: 9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 6 centers

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

Identifiers

NCT: NCT05345587 · PHRC-I/2019/FF-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗