CancerPROLIFENCT05345587
Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
A study testing THESS monitoring in people with Cancer, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- THESS monitoring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 6 sitesFrance
- Study dates
- 16 Sep 2022to Oct 2026
- 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 starting oral therapy treatment in oncology for metastatic or locally advanced cancer
- Patient able to use a connected electronic object
- Patient with a smartphone/tablet or computer with internet access and an email address.
- Patient with WHO status ≤2
- Patients receiving other cancer therapy concurrently with oral therapy may be included
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant, parturient or breast feeding
- Illiterate patient
- Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
- Patient receiving hormone therapy alone for breast or prostate cancer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Centre Hospitalier Dubois Brive
Brive-la-Gaillarde, 19100
Nicolas MADRANGES
Nicolas MADRANGES
- Recruiting
Chic Castres-Mazamet
Castres, 81108
BOTIN
Teresa BOTIN
- Recruiting
Centre Hospitalier Emile ROUX
Le Puy-en-Velay, 43 012
Brigitte MONANGE
Brigitte MONANGE
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Frédéric Fiteni
- Recruiting
Institut cancerologie du Gard
Nîmes
Eric Legouffe, legouffe.oncogard@orange.fr
Eric Legouffe
- Recruiting
Médipôle Lyon-Villeurbanne
Villeurbanne, 69100
Marie BEGUINOT
Marie BEGUINOT
About this study
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.
Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.
Read more
Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.
Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.
- Conditions
- Cancer
- Being tested
- THESS monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THESS monitoringOther
Consultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days
| Study group | Role | What they receive |
|---|---|---|
| Prolife group | Experimental | scheduled consultation with the hospital clinical pharmacist, therapeutic follow-up and collection of clinical information by the patient via the THESS monitoring system Receives: Other: THESS monitoring |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until decrease in quality of life by 5-points between groups
Quality of life calculated every 3 months using EORTC QLQ-C30 for which a decrease of 5-points is considered to be the minimal clinically important difference
Measured: End of follow-up maximum 18 months
Secondary outcomes (35)
Time until progression of cancer between groups
Measured every 3 months by the Response Evaluation Criteria in Solid Tumours (RECIST) criteria, classed as: Complete response (CR), Partial response (PR), Stable disease (SD), or Progressive disease (PD)
Measured: End of follow-up maximum 18 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 3 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 6 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 9 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 12 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 15 months
Patient satisfaction with their treatment between groups
The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.
Measured: 18 months
Quality of life adjusted years between groups
EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number
Measured: 18 months
Cost of care between groups
The cost of the system will be estimated from the point of view of the health care institution by valuing the time of the medical and nursing staff and patient out-of-pocket expenses
Measured: End of study (18 months)
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 3 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 6 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 9 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 12 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 15 months
Toxicity experienced during treatment between groups
National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 18 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 3 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 6 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 9 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 12 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 15 months
Relative Dose Intensity between groups
% doses received/dose planned
Measured: 18 months
Budget Impact Analysis
Cost of care for the population reached (actual population treated) on a national scale in Euros
Measured: After 2 years
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 3 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 6 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 9 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 12 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 15 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Measured: 18 months
Medication observance
Girerd questionnaire; score 0-6
Measured: 3 months
Medication observance
Girerd questionnaire; score 0-6
Measured: 6
Medication observance
Girerd questionnaire; score 0-6
Measured: 9 months
Medication observance
Girerd questionnaire; score 0-6
Measured: 12 months
Medication observance
Girerd questionnaire; score 0-6
Measured: 15 months
Medication observance
Girerd questionnaire; score 0-6
Measured: 18 months
Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes
System Usability Scale questionnaire; score 0-100
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start16 Sep 2022
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Fiteni, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345587
- Sponsor's protocol ID
- PHRC-I/2019/FF-01
- Acronym
- PROLIFE
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy
- ClinicalTrials.gov ID
- NCT05345587
- Acronym / sponsor ID
- PROLIFE / PHRC-I/2019/FF-01
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Apr 2022 (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.
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.
Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.
Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.
Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolife group | Experimental | Other: THESS monitoringscheduled consultation with the hospital clinical pharmacist, therapeutic follow-up and collection of clinical information by the patient via the THESS monitoring system |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
- Patient able to use a connected electronic object
- Patient with a smartphone/tablet or computer with internet access and an email address.
- Patient with WHO status ≤2
- Patients receiving other cancer therapy concurrently with oral therapy may be included
Key exclusion criteria (8 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient pregnant, parturient or breast feeding
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 |
|---|---|---|
| THESS monitoringConsultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days | Other | Prolife group |
Primary outcome
Time until decrease in quality of life by 5-points between groups
Time frame: End of follow-up maximum 18 months
Quality of life calculated every 3 months using EORTC QLQ-C30 for which a decrease of 5-points is considered to be the minimal clinically important difference
35 secondary outcomes
Time until progression of cancer between groups
Time frame: End of follow-up maximum 18 months
Patient satisfaction with their treatment between groups
Time frame: 3 months
Patient satisfaction with their treatment between groups
Time frame: 6 months
Patient satisfaction with their treatment between groups
Time frame: 9 months
Patient satisfaction with their treatment between groups
Time frame: 12 months
Patient satisfaction with their treatment between groups
Time frame: 15 months
Patient satisfaction with their treatment between groups
Time frame: 18 months
Quality of life adjusted years between groups
Time frame: 18 months
Cost of care between groups
Time frame: End of study (18 months)
Toxicity experienced during treatment between groups
Time frame: 3 months
Toxicity experienced during treatment between groups
Time frame: 6 months
Toxicity experienced during treatment between groups
Time frame: 9 months
Toxicity experienced during treatment between groups
Time frame: 12 months
Toxicity experienced during treatment between groups
Time frame: 15 months
Toxicity experienced during treatment between groups
Time frame: 18 months
Relative Dose Intensity between groups
Time frame: 3 months
Relative Dose Intensity between groups
Time frame: 6 months
Relative Dose Intensity between groups
Time frame: 9 months
Relative Dose Intensity between groups
Time frame: 12 months
Relative Dose Intensity between groups
Time frame: 15 months
Relative Dose Intensity between groups
Time frame: 18 months
Budget Impact Analysis
Time frame: After 2 years
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 3 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 6 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 9 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 12 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 15 months
Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).
Time frame: 18 months
Medication observance
Time frame: 3 months
Medication observance
Time frame: 6
Medication observance
Time frame: 9 months
Medication observance
Time frame: 12 months
Medication observance
Time frame: 15 months
Medication observance
Time frame: 18 months
Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes
Time frame: Month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Frédéric Fiteni principal investigator
CHU de Nimes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THESS monitoring in people with Cancer, run by Centre Hospitalier Universitaire de Nīmes at 6 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 7 inclusion and 8 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Frédéric Fiteni (04.34.03.46.69, frederic.fiteni@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until decrease in quality of life by 5-points between groups (time frame: End of follow-up maximum 18 months). 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 26 Apr 2024.