Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The DROP program of pharmaceutical interventions, Standard of care.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Behavioral The DROP program of pharmaceutical interventions
Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions. - Behavioral Standard of care
In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.
Primary outcome measures
- Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category [Time frame: 9 months post-inclusion]
Secondary outcome measures (12)
- Total number of DRP related to all prescribed drugs per patient [Time frame: 6 months and 9 months post-inclusion]
- Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient [Time frame: 6 months and 9 months post-inclusion]
- Relative dose intensity of the oral anticancer drug [Time frame: 6 months post-inclusion]
- Adherence to the oral anticancer drug [Time frame: 6 months post-inclusion]
- Number of imaging acts and nature of acts [Time frame: During the 6 months of follow-up]
- Number of acts of biology and nature of acts [Time frame: During the 6 months of follow-up]
- Number of medical consultations [Time frame: During the 6 months of follow-up]
- Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs [Time frame: During the 6 months of follow-up]
- Number of hospital admissions [Time frame: During the 6 months of follow-up]
- Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire [Time frame: At inclusion and 6 months from the treatment initiation]
- Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire [Time frame: At inclusion and 6 months from the treatment initiation]
- Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale [Time frame: At inclusion and 6 months from the treatment initiation]
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.
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
- Supportive care
Study locations
France · 1 center
- Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon S — Pierre-Bénite
Publications
- Ranchon F, Huot L, Bardin C, Madelaine I, Cazin JL, Pourroy B, Tilleul P, Lemare F, Rioufol C. Randomised controlled trial to assess the impact of hospital-community pharmaceutical care on drug-related problems in oncology practice for at-risk outpatients treated with oral anticancer drugs-a French Society for Oncology Pharmacy (SFPO) study: DROP-SFPO study protocol. BMJ Open. 2025 Jun 27;15(6):e0 PMID 40578885
Identifiers
NCT: NCT03257969 · 69HCL17_0029