Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors

NCT03257969 | Recruiting

• 1 other identifier: 69HCL17_0029
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Oral chemotherapy; Health related program; Secured drug intake; Pharmacist intervention; Cancer outpatient

Outcome Measures

Primary Outcomes (1)

• Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category

  DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).

  9 months post-inclusion

Secondary Outcomes (20)

• Total number of DRP related to all prescribed drugs per patient

  6 months and 9 months post-inclusion

• Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient

  6 months and 9 months post-inclusion

• Relative dose intensity of the oral anticancer drug

  6 months post-inclusion

• Adherence to the oral anticancer drug

  6 months post-inclusion

• Number of imaging acts and nature of acts

  During the 6 months of follow-up

Study Arms (2)

The DROP program

EXPERIMENTAL

Behavioral: The DROP program of pharmaceutical interventions

Standard of care

OTHER

Behavioral: Standard of care

Interventions

The DROP program of pharmaceutical interventions BEHAVIORAL

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.

The DROP program

Standard of care BEHAVIORAL

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

Related Publications (1)

• 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):e094825. doi: 10.1136/bmjopen-2024-094825.

  PMID: 40578885 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Catherine RIOUFOL, PharmD

CONTACT

04 78 86 43 70; catherine.rioufol@chu-lyon.fr

Laure HUOT, PharmD

CONTACT

04 72 11 57 62; laure.huot@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 22, 2017
• Study Start: June 18, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)