CancerDROP-SFPONCT03257969
Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
A study testing The DROP program of pharmaceutical interventions in people with Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- The DROP program of pharmaceutical interventions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2019to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Catherine RIOUFOL, PharmD, 04 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr
Laure HUOT, PharmD, 04 72 11 57 62 ext. +33, laure.huot@chu-lyon.fr
About this study
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
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
- Being tested
- The DROP program of pharmaceutical interventions, Standard of care
- Keywords
- Oral chemotherapy, Health related program, Secured drug intake, Pharmacist intervention, Cancer outpatient
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DROP program of pharmaceutical interventionsBehavioural
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.
Standard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The DROP program | Experimental | Not described Receives: Behavioral: The DROP program of pharmaceutical interventions |
| Standard of care | Other | Not described Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months post-inclusion
Secondary outcomes (20)
Total number of DRP related to all prescribed drugs per patient
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).
Measured: 6 months and 9 months post-inclusion
Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient
dose adjustments, cure spacing, interruptions and cessation of treatment.
Measured: 6 months and 9 months post-inclusion
Relative dose intensity of the oral anticancer drug
Relative dose intensity will be computed by the ratio between the overall dose prescribed during the 6 months of follow-up and the theoretical dosage according to the summary of product characteristics of the market authorization.
Measured: 6 months post-inclusion
Adherence to the oral anticancer drug
Adherence will be measured with the Girerd questionnaire score 6 items from the Ameli Health Insurance website and the rate of prescription renewal by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
Measured: 6 months post-inclusion
Number of imaging acts and nature of acts
To evaluate consumption of unscheduled ambulatory care related to DRP
Measured: During the 6 months of follow-up
Number of acts of biology and nature of acts
To evaluate consumption of unscheduled ambulatory care related to DRP
Measured: During the 6 months of follow-up
Number of medical consultations
To evaluate consumption of unscheduled ambulatory care related to DRP
Measured: During the 6 months of follow-up
Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs
To evaluate consumption of unscheduled ambulatory care related to DRP
Measured: During the 6 months of follow-up
Number of hospital admissions
To evaluate unplanned hospital admissions related to DRP
Measured: During the 6 months of follow-up
Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire
Measured: At inclusion and 6 months from the treatment initiation
Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire
Measured: At inclusion and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Measured: At inclusion and 6 months from the treatment initiation
Number of interventions of primary care actors with the patient
To evaluate the involvement of primary care actors in the DROP program
Measured: During the 9 months of follow-up
Number of time the Oncolien website was used by ambulatory care pharmacists
To evaluate the involvement of primary care actors in the DROP program
Measured: During the 9 months of follow-up
Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists
To evaluate the involvement of primary care actors in the DROP program
Measured: During the 9 months of follow-up
Number of patient-advice forms downloaded and delivered to the patient
To evaluate the involvement of primary care actors in the DROP program
Measured: During the 9 months of follow-up
Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing
To evaluate the involvement of primary care actors in the DROP program
Measured: During the 9 months of follow-up
Patient's satisfaction for the DROP program
Satisfaction will be measured with a 10-point visual analog scale.
Measured: At 9 months post-inclusion
Ambulatory care physician's and pharmacist's satisfactions with the DROP program
Satisfaction will be measured with a 10-point visual analog scale.
Measured: At 9 months post-inclusion
Efficiency of the DROP program
Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care.
Measured: 9 months post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start18 Jun 2019
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257969
- Sponsor's protocol ID
- 69HCL17_0029
- Acronym
- DROP-SFPO
- Status last verified
- Mar 2025
- First submitted
- 27 Jul 2017
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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):e094825. doi: 10.1136/bmjopen-2024-094825.
PubMed 40578885
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03257969
- Acronym / sponsor ID
- DROP-SFPO / 69HCL17_0029
- Conditions
- Cancer
- Keywords
- Oral chemotherapy, Health related program, Secured drug intake, Pharmacist intervention, Cancer outpatient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The DROP program | Experimental | Behavioral: The DROP program of pharmaceutical interventions |
| Standard of care | Other | Behavioral: Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The DROP program of pharmaceutical interventionsMultidisciplinary 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. | Behavioural | The DROP program |
| Standard of careIn 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. | Behavioural | Standard of care |
Primary outcome
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
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).
20 secondary outcomes
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
Number of interventions of primary care actors with the patient
Time frame: During the 9 months of follow-up
Number of time the Oncolien website was used by ambulatory care pharmacists
Time frame: During the 9 months of follow-up
Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists
Time frame: During the 9 months of follow-up
Number of patient-advice forms downloaded and delivered to the patient
Time frame: During the 9 months of follow-up
Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing
Time frame: During the 9 months of follow-up
Patient's satisfaction for the DROP program
Time frame: At 9 months post-inclusion
Ambulatory care physician's and pharmacist's satisfactions with the DROP program
Time frame: At 9 months post-inclusion
Efficiency of the DROP program
Time frame: 9 months post-inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 40578885Ranchon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The DROP program of pharmaceutical interventions in people with Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine RIOUFOL, PharmD (04 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.