Improving management of drug-related problems in cancer patients on oral chemotherapy
Impact of the DROP (Drug Related Problems in Oncology Practice) Program of Pharmaceutical Interventions of the French Society of Oncological Pharmacology Versus Usual Care on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
This study is testing a new program to help cancer patients taking oral chemotherapy manage their medications better and reduce side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT03257969 on ClinicalTrials.gov |
What this trial studies
This study evaluates the DROP program, which aims to address drug-related problems (DRP) in cancer patients receiving oral anticancer medications. It focuses on outpatient care, where patients may face risks such as non-adherence and inappropriate management of side effects. The program involves pharmaceutical interventions to enhance coordination between hospital and outpatient care, particularly for older patients with multiple comorbidities. The goal is to improve treatment efficacy and reduce toxicity through better management of oral chemotherapy regimens.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged 18 or older who are starting or changing their oral anticancer medication and are taking multiple other medications.
Not a fit: Patients who are not on oral anticancer drugs or those who are hospitalized for their treatment may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the safety and effectiveness of oral anticancer treatments for patients.
How similar studies have performed: Previous studies have indicated that coordinated pharmaceutical interventions can effectively reduce drug-related problems in outpatient settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pierre-Bénite
- Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Catherine RIOUFOL, PharmD
- Email: catherine.rioufol@chu-lyon.fr
- Phone: 04 78 86 43 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.