Back to results

Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy (IPPACTTO)

Primary Purpose

Advanced or Metastatic Solid Tumor, Relapsed Hematologic Malignancy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

IPPACTTO

About this trial

This is an interventional supportive care trial for Advanced or Metastatic Solid Tumor focused on measuring Anti cancer oral therapy, Pharmaceutical intervention, Adverse events, Drug interactions, Coordinated care pathway, Drug related problem, Adherence, Quality of life, Pharmaceutical care, Clinical pharmacy, Oncology pharmacy, Hospital pharmacist, Patient satisfaction, Patient care team, Community pharmacist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged 18 years old or more
Having given his written consent to participate in the study
Patients with advanced or metastatic solid tumor or relapsed hematologic malignancy
With an initiation of oral therapy
Performance Status 0, 1 or 2

Exclusion Criteria:

Patient receiving ongoing intravenous (IV) or subcutaneous (SC) anticancer treatment
Patient receiving ongoing oral therapy
Patient receiving first-generation hormone therapy
Patient receiving ongoing a coordinated pharmaceutical path
Patient participating in a therapeutic education program including a pharmacist
Patient already included in an interventional clinical trial
Oral therapy with Temporary Authorisation
Patient in a health or medico-social institution
Patient protected, under guardianship or unable to give free and informed consent
Patient does not speak French
Patient unable to read French
Patient unable to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
Patients 70 years old with cognitive disorders identified by the G-CODE

Sites / Locations

Institut de Cancérologie de l'OuestRecruiting
CHURecruiting
Ch CholetRecruiting
CHD VendéeRecruiting
Ch Le MansRecruiting
Chu NantesRecruiting
Institut de Cancérologie de l'OuestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coordinated pharmaceutical path

Standard of care

Arm Description

Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

Outcomes

Primary Outcome Measures

Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.

The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Secondary Outcome Measures

Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy

The impact will be measured by the number of grade 3 and 4 adverse events occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy

Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.

Impact of the coordinated pharmaceutical path on the drug related problems.

Number and nature of potential and confirmed drug related problemS detected by pharmacists

Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy

Number of treatment modifications related to oral therapy, necessary before starting treatment and during oral therapy and confirmed by the oncologist during follow-up consultations

Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire

Quality of life for patients will be evaluated by a questionnaire before and after starting oral therapy according to the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

Impact of the coordinated pharmaceutical path on adherence to the oral therapy

Adherence to the oral therapy measured with the Girerd questionnaire wich is composed of 6 questions with an expected answer yes or no. A "yes" answer is worth 1, "No" answer is worth 0. The maximum score obtained is 6; the minimum score is 0. Final Score> 2: low compliance ; Final score = 1 or 2: average compliance ; Final score = 0: good compliance.

Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire

Satisfaction of patients will be evaluated by a series of questions related to oral therapy. The patient responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree. An overall score is also required between 1 and 10; 1 is very bad; 10 is perfect

Assessment of the link between hospital and city

Evaluation of the link will be performed by a questionnaire to be completed by the oncologist and pharmacists. Each responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree

Full Information

NCT ID

NCT04327583

First Posted

March 13, 2020

Last Updated

April 21, 2022

Sponsor

Institut Cancerologie de l'Ouest

1. Study Identification

Unique Protocol Identification Number

NCT04327583

Brief Title

Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy

Acronym

IPPACTTO

Official Title

Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 7, 2021 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced or Metastatic Solid Tumor, Relapsed Hematologic Malignancy

Keywords

Anti cancer oral therapy, Pharmaceutical intervention, Adverse events, Drug interactions, Coordinated care pathway, Drug related problem, Adherence, Quality of life, Pharmaceutical care, Clinical pharmacy, Oncology pharmacy, Hospital pharmacist, Patient satisfaction, Patient care team, Community pharmacist

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coordinated pharmaceutical path

Arm Type

Experimental

Arm Description

Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Arm Title

Standard of care

Arm Type

No Intervention

Arm Description

Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

Intervention Type

Behavioral

Intervention Name(s)

IPPACTTO

Intervention Description

The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist. Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician.

Primary Outcome Measure Information:

Title

Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.

Description

The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Time Frame

6 months from the treatment initiation

Secondary Outcome Measure Information:

Title

Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy

Description

The impact will be measured by the number of grade 3 and 4 adverse events occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Time Frame

6 months from the treatment initiation

Title

Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy

Description

Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.

Time Frame

6 months from the treatment initiation

Title

Impact of the coordinated pharmaceutical path on the drug related problems.

Description

Number and nature of potential and confirmed drug related problemS detected by pharmacists

Time Frame

6 months from the treatment initiation

Title

Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy

Description

Number of treatment modifications related to oral therapy, necessary before starting treatment and during oral therapy and confirmed by the oncologist during follow-up consultations

Time Frame

6 months from the treatment initiation

Title

Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire

Description

Time Frame

Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation

Title

Impact of the coordinated pharmaceutical path on adherence to the oral therapy

Description

Time Frame

1 month ; 3 months and 6 months from the treatment initiation

Title

Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire

Description

Time Frame

6 months from the treatment initiation

Title

Assessment of the link between hospital and city

Description

Evaluation of the link will be performed by a questionnaire to be completed by the oncologist and pharmacists. Each responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree

Time Frame

Through study completion, an average of 42 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged 18 years old or more Having given his written consent to participate in the study Patients with advanced or metastatic solid tumor or relapsed hematologic malignancy With an initiation of oral therapy Performance Status 0, 1 or 2 Exclusion Criteria: Patient receiving ongoing intravenous (IV) or subcutaneous (SC) anticancer treatment Patient receiving ongoing oral therapy Patient receiving first-generation hormone therapy Patient receiving ongoing a coordinated pharmaceutical path Patient participating in a therapeutic education program including a pharmacist Patient already included in an interventional clinical trial Oral therapy with Temporary Authorisation Patient in a health or medico-social institution Patient protected, under guardianship or unable to give free and informed consent Patient does not speak French Patient unable to read French Patient unable to undergo the medical monitoring of the trial for geographical, social or psychological reasons. Patients 70 years old with cognitive disorders identified by the G-CODE

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fanny D'ACREMONT-JUTIER

Phone

02 40 84 64 47

fanny.jutier@chu-nantes.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Emilie DEBEAUPUIS

emilie.debeaupuis@ico.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fanny D'ACREMONT-JUTIER

Organizational Affiliation

OMEDIT Pays de la Loire

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cancérologie de l'Ouest

City

Angers

ZIP/Postal Code

49055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elouen BOUGHALEM, MD

elouen.boughalem@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Elouen BOUGHALEM, MD

Facility Name

CHU

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathilde HUNAULT Mathilde, MD

mahunault@chu-angers.fr

First Name & Middle Initial & Last Name & Degree

Mathilde HUNAULT Mathilde, MD

Facility Name

Ch Cholet

City

Cholet

ZIP/Postal Code

49300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victor SIMMET, MD

victor.simmet@ch-cholet.fr

First Name & Middle Initial & Last Name & Degree

Victor SIMMET, MD

Facility Name

CHD Vendée

City

La Roche-sur-Yon

ZIP/Postal Code

85925

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadine MORINEAU Nadine, MD

nadine.morineau@chd-vendee.fr

First Name & Middle Initial & Last Name & Degree

Nadine MORINEAU Nadine, MD

Facility Name

Ch Le Mans

City

Le Mans

ZIP/Postal Code

72037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oana COJOCARASU, MD

COJOCARASUOANA@ch-lemans.fr

First Name & Middle Initial & Last Name & Degree

Oana COJOCARASU, MD

Facility Name

Chu Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas BLIN, MD

nicolas.blin@chu-nantes.fr

First Name & Middle Initial & Last Name & Degree

Nicolas BLIN, MD

Facility Name

Institut de Cancérologie de l'Ouest

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuelle BOURBOULOUX, MD

emmanuelle.bourbouloux@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Emmanuelle BOURBOULOUX, MD

12. IPD Sharing Statement

Learn more about this trial

Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy

We'll reach out to this number within 24 hrs