NCT03257969 Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
| NCT ID | NCT03257969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2019-06-18 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 248 participants in total. It began in 2019-06-18 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. Latrogenic risk of these treatments is reinforced in older patients with frequent comorbidities, taking multiple pharmaceutical treatments for long periods and followed by several prescribers. The literature reports an emergence of drug related problems (DRP) in more than 90% of patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced efficacy and potentiation of toxicity) are all the more important that outpatient monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings. Medical care and prevention of these DRP are difficult because of a lack of information and tools shared between hospital and liberal actors. Experiments are developed according to different organizational models, frequently focused on the pharmaceutical analysis of prescriptions, the detection of DRP and their control, but they stay still undervalued. In this context, the French Society of Oncological Pharmacology (SFPO - Société Française de Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien website and proposes to assess the impact of a program of pharmaceutical interventions named DROP. The hypothesis of the study is that the DROP program will secure the medical care of patients with oral anticancer drugs compared to the usual care.
Eligibility Criteria
Inclusion Criteria: * Patient aged 18 years old or more * With cancer * For wich the initiation or change of an oral anticancer drug is prescribed * With life expectancy estimated to be 6 months or more, in the opinion of the investigator * Of which the treatment with oral anticancer medication is estimated to be 6 months or more in the opinion of the oncologist * Benefiting from an initiation or a change of oral anticancer agents according to the MA: cytotoxic agent, targeted therapy, hormonal therapy (excluding adjuvant treatments); * of which the oral anticancer drug is delivered in pharmacy of town or in retrocession hospital; * With ambulatory status (not hospitalized for the management and treatment ) * Taking 5 or more drugs, including the oral anticancer treatment, and / or treated with an oral anticancer drug requiring complex regimen (combination of 2 oral anticancer drugs, or sequential rate of intake, or associated to intravenous chemotherapy) * With a sufficient autonomy for the management of medication at home * Without either cognitive disorders or major psychiatric disorders, in the opinion of the investigator * Ability to read, write and understand the French language * Having given his written consent to participate in the study * Patient affiliated to the social security scheme or equivalent Exclusion Criteria: * Pregnant or lactating woman * Patient on anti-PD1, anti-PDL-1 or anti-CTLA4-4 immunotherapy concomitant with oral anticancer treatment * Patient under radiotherapy concomitant treatment with oral anticancer * Oral anticancer agent prescribed in a delivery circuit as part of an ATU or clinical trial; * Patient with significant cognitive or psychiatric disorders, in the opinion of the investigator; * Management of drug treatment at home is performed exclusively by the caregiver; * Not having declared a doctor; * Not having a usual city pharmacy, or reporting 2 or more usual city pharmacies; * Patient who has already benefited from a therapeutic education program * In institution or guardianship, major protected by the Law.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03257969 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03257969 currently recruiting?
Yes, NCT03257969 is actively recruiting participants. Contact the research team at catherine.rioufol@chu-lyon.fr for enrollment information.
Where is the NCT03257969 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT03257969 clinical trial?
NCT03257969 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 248 participants.
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