Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05345587
Other study ID # PHRC-I/2019/FF-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2022
Est. completion date October 2026

Study information

Verified date April 2024
Source Centre Hospitalier Universitaire de Nimes
Contact Frédéric Fiteni
Phone 04.34.03.46.69
Email frederic.fiteni@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date October 2026
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
THESS monitoring
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

Locations

Country Name City State
France Centre Hospitalier Dubois Brive Brive-la-Gaillarde
France Chic Castres-Mazamet Castres
France Centre Hospitalier Emile ROUX Le Puy en Velay
France CHU de Nîmes Nîmes
France Institut cancerologie du Gard Nîmes
France Médipôle Lyon-Villeurbanne Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 End of follow-up maximum 18 months
Secondary 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) End of follow-up maximum 18 months
Secondary 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. 3 months
Secondary 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. 6 months
Secondary 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. 9 months
Secondary 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. 12 months
Secondary 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. 15 months
Secondary 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. 18 months
Secondary Quality of life adjusted years between groups EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number 18 months
Secondary 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 End of study (18 months)
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 3 months
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 6 months
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 9 months
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 12 months
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 15 months
Secondary Toxicity experienced during treatment between groups National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 18 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 3 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 6 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 9 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 12 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 15 months
Secondary Relative Dose Intensity between groups % doses received/dose planned 18 months
Secondary Budget Impact Analysis Cost of care for the population reached (actual population treated) on a national scale in Euros After 2 years
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 3 months
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 6 months
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 9 months
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 12 months
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 15 months
Secondary Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy). 18 months
Secondary Medication observance Girerd questionnaire; score 0-6 3 months
Secondary Medication observance Girerd questionnaire; score 0-6 6
Secondary Medication observance Girerd questionnaire; score 0-6 9 months
Secondary Medication observance Girerd questionnaire; score 0-6 12 months
Secondary Medication observance Girerd questionnaire; score 0-6 15 months
Secondary Medication observance Girerd questionnaire; score 0-6 18 months
Secondary Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes System Usability Scale questionnaire; score 0-100 Month 18
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients