Advanced or Metastatic Solid TumorIPPACTTONCT04327583
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
A study testing IPPACTTO in people with Advanced or Metastatic Solid Tumor and Relapsed Hematologic Malignancy, run by Institut Cancerologie de l'Ouest at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumor, Relapsed Hematologic Malignancy
- What is being tested?
- IPPACTTO
- 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
- 396 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Apr 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
Emilie DEBEAUPUIS contact
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Angers, 49055
Elouen BOUGHALEM, MD, elouen.boughalem@ico.unicancer.fr
Elouen BOUGHALEM, MD
- Recruiting
CHU
Angers, 49933
Mathilde HUNAULT Mathilde, MD, mahunault@chu-angers.fr
Mathilde HUNAULT Mathilde, MD
- Recruiting
Ch Cholet
Cholet, 49300
Victor SIMMET, MD, victor.simmet@ch-cholet.fr
Victor SIMMET, MD
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85925
Nadine MORINEAU Nadine, MD, nadine.morineau@chd-vendee.fr
Nadine MORINEAU Nadine, MD
- Recruiting
Ch Le Mans
Le Mans, 72037
Oana COJOCARASU, MD, COJOCARASUOANA@ch-lemans.fr
Oana COJOCARASU, MD
- Recruiting
Chu Nantes
Nantes, 44093
Nicolas BLIN, MD, nicolas.blin@chu-nantes.fr
Nicolas BLIN, MD
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Emmanuelle BOURBOULOUX, MD, emmanuelle.bourbouloux@ico.unicancer.fr
Emmanuelle BOURBOULOUX, MD
About this study
Official title: Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy
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
- Being tested
- IPPACTTO
- 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
- Medical subject headings
- Neoplasm Metastasis, Hematologic Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPPACTTOBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coordinated pharmaceutical path | Experimental | Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist Receives: Behavioral: IPPACTTO |
| Standard of care | No intervention | Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months from the treatment initiation
Secondary outcomes (8)
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.
Measured: 6 months from the treatment initiation
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.
Measured: 6 months from the treatment initiation
Impact of the coordinated pharmaceutical path on the drug related problems.
Number and nature of potential and confirmed drug related problemS detected by pharmacists
Measured: 6 months from the treatment initiation
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
Measured: 6 months from the treatment initiation
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
Measured: Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation
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.
Measured: 1 month ; 3 months and 6 months from the treatment initiation
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
Measured: 6 months from the treatment initiation
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
Measured: Through study completion, an average of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start7 Apr 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorStudies of the same condition, open and under way.
- 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
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny D'ACREMONT-JUTIER, Principal investigator, OMEDIT Pays de la Loire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327583
- Sponsor's protocol ID
- ICO-2019-07
- Acronym
- IPPACTTO
- Status last verified
- Apr 2022
- First submitted
- 13 Mar 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy
- ClinicalTrials.gov ID
- NCT04327583
- Acronym / sponsor ID
- IPPACTTO / ICO-2019-07
- Keywords
- Anti cancer oral therapy, Pharmaceutical intervention, Adverse events, Drug interactions, Coordinated care pathway, Drug related problem, Adherence, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 31 Mar 2020 (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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated pharmaceutical path | Experimental | Behavioral: IPPACTTOPatients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist |
| Standard of care | No intervention | –Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| IPPACTTOThe 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. | Behavioural | Coordinated pharmaceutical path |
Primary outcome
Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer.
Time frame: 6 months from the treatment initiation
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.
8 secondary outcomes
Impact of the coordinated pharmaceutical path on the number of grade 3 and 4 adverse events detected linked to oral therapy
Time frame: 6 months from the treatment initiation
Impact of the coordinated pharmaceutical path on unplanned hospitalizations related to the oral therapy
Time frame: 6 months from the treatment initiation
Impact of the coordinated pharmaceutical path on the drug related problems.
Time frame: 6 months from the treatment initiation
Detection of concerted treatment modifications between oncologist and pharmacist related to oral therapy
Time frame: 6 months from the treatment initiation
Impact of the coordinated pharmaceutical path on quality of life: EORTC QLQ-C30 questionnaire
Time frame: Inclusion ; 1 month ; 3 months and 6 months from the treatment initiation
Impact of the coordinated pharmaceutical path on adherence to the oral therapy
Time frame: 1 month ; 3 months and 6 months from the treatment initiation
Satisfaction of patients related to the coordinated pharmaceutical path: questionnaire
Time frame: 6 months from the treatment initiation
Assessment of the link between hospital and city
Time frame: Through study completion, an average of 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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. This study is not recruiting at the moment.
Emilie DEBEAUPUIS contact
Fanny D'ACREMONT-JUTIER principal investigator
OMEDIT Pays de la Loire
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPPACTTO in people with Advanced or Metastatic Solid Tumor and Relapsed Hematologic Malignancy, run by Institut Cancerologie de l'Ouest at 7 sites 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny D'ACREMONT-JUTIER (02 40 84 64 47, fanny.jutier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the coordinated pharmaceutical path on the tolerance of oral therapies against cancer. (time frame: 6 months from the treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2022.