Medico-economic Evaluation of the ONCORAL Program for Ambulatory Patients Under Oral Anticancer Drugs Versus Usual Care

NCT03660670 | Unknown

• 1 other identifier: 69HCL18_0046
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

Economic impact of cancer treatments is increasing for years: increase of number of patients (385 000 new occurrences in 2015), increase of life expectancies, chronicization of diseases and increase of therapeutic innovation costs. Oral anticancer drugs allow the ambulatory turn in oncologic treatments, avoid hospitalizations dues to injectable chemotherapies and improve patient autonomy. In real life situation, these drugs still remain linked to significant drug iatrogenic effects: prevalent adverse events and potentially serious ones, drugs interactions for one other patient, considered as major in 15-20% cases, and non-observance for 30-50% patients. The resultant care overconsumption and the high cost of new oral targeted therapies appear as a substantial financial charge to the Health related program. Securing oral chemotherapy and their good practice therefore represent a real economic challenge and lead health care professionals to develop town-hospital programs of ambulatory patient's follow-up under oral anticancer drug in response of third Cancer Plan. Benefice of such interventions are proved on observance, management of adverse events and drug interactions. However, the effectiveness of these programs has not been evaluated and no studies have been conducted in France. The Investigators propose here to carry out a medico-economic study of high level of proof of the ONCORAL program. This study will be the first evaluation of the effectiveness of a program for monitoring outpatient oral cancer patients versus usual care. The results of this study will contribute to the national reflection on the path of care of patients treated by oral chemotherapy, on the assessment of needs and the evolution of the supply of care and its financing.

Conditions

Cancer

Keywords

Oral chemotherapy; cancer outpatient; ONCORAL; medico-economic; Health related program; multidisciplinary; therapeutic education

Outcome Measures

Primary Outcomes (1)

• Evaluate efficiency of ONCORAL program for ambulatory patients under oral anticancer drugs versus usual care

  Efficiency is calculated on the double dimension cost and year of life corrected by quality of life (QALY).

  Month 12

Secondary Outcomes (21)

• Evaluate the cost price in charge for the two strategies

  Month 12

• Patient's quality of life, measured with the EQ-5D-3L (EuroQol Group-5 dimensions-3 levels) questionnaire

  at inclusion, 3 months, 6 months and 12 months post inclusion

• Budget impact analysis of 12-months of ONCORAL care.

  12 months

• Oral anti-cancer dose taken relative to the dose of the marketing authorization

  3, 6 and 12 months post-inclusion

• Reasons for modifications of relative dose-intensity

  3, 6 and 12 months post-inclusion

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Application of the ONCORAL program of multidisciplinary ONCOlogic interventions between town and hospital (doctor-pharmacist-nurse) for ambulatory patients under oRAL anticancer drugs

Behavioral: ONCORAL therapeutic education

Standard of care

SHAM COMPARATOR

Patients in the control group will receive regular follow-up from their oncologist, but no more that the standard care.

Behavioral: Standard of care

Interventions

ONCORAL therapeutic education BEHAVIORAL

Multidisciplinary program that includes informative cessions with a hospital pharmacist about the anticancer drug: information is given to the patients on adverse events and their managements, optimizing drug dosage plans. Moreover, information is shared with town partners: doctor, pharmacists, and nurses.

Interventional Arm

Standard of care BEHAVIORAL

In the group of standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessments.

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:

• Adult more than 18 years-old
• Cancer patient
• For whom an initiation or a change of oral anticancer is prescribed according to the AMM
• Considered by the oncologist as at iatrogenic drug risk, or having 3 or more risk factors, to develop an iatrogenic drug issue among the following risk factors:
• ≥ 2 oral anticancer drugs,
• ≥ 2 lines of treatment,
• combination with an injectable chemotherapy,
• rhythm discontinuous intake of oral anticancer,
• ≥ 2 associated chronic conditions,
• number of associated drugs including oral anticancer ≥5,
• creatinine clearance \<60 ml / min,
• frailties and psychosocial conditions at risk (isolated patient, foreign, having limited autonomy)
• without major psychiatric cognitive impairment that may interfere with the ONCORAL program;
• in sufficient autonomy to manage his home treatment;
• signed a written informed consent to participate;

You may not qualify if:

• Treated with oral anticancer in a clinical trial or temporal use authorization
• Management of oral anticancer treatment exclusively by the caregiver;
• Who did not report a regular physician or pharmacy, or who reported ≥2 or more regular street pharmacies;
• In an institution or guardianship, a major protected by the law;
• Participation in a clinical trial that may alter the costs of care.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

Related Publications (1)

• Huot L, Guerre P, Descotes G, Caffin AG, Herledan C, Ranchon F, Rioufol C. Cost-effectiveness of the ONCORAL multidisciplinary programme for the management of outpatients taking oral anticancer agents at risk of drug-related event: protocol for a pragmatic randomised controlled study. BMJ Open. 2024 Feb 17;14(2):e074956. doi: 10.1136/bmjopen-2023-074956.

  PMID: 38367968 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

Study Officials

• Catherine RIOUFOL, PharmD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine RIOUFOL, PharmD

CONTACT

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

Magali MAIRE

CONTACT

04 78 86 43 34; magali.maire@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: August 16, 2018
• First Posted: September 6, 2018
• Study Start: December 2, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)