Cancer Clinical Trial
— eRToMSyOfficial title:
Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment
Verified date | January 2022 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the psychometric properties (validity, reliability and responsiveness) of the QuestOnco tool, an electronic Remote Toxicity Management System, in adult cancer patients receiving an active anti-cancer treatment.
Status | Completed |
Enrollment | 134 |
Est. completion date | January 12, 2022 |
Est. primary completion date | January 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults (=18 years); - Written and informed consent; - Diagnosis of solid cancer; - Metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments; - Patient physically/psychologically fit to participate in the study; - Patient able to understand, communicate and use the electronic device; - Patient owning a smartphone or tablet with internet connection; - Treatment supported by the French social security system. Exclusion Criteria: - Unable patient for signing informed consent; - Unable to understand, communicate and use the electronic device; - Patient under trusteeship or guardianship; - Patient under legal or administration protection. |
Country | Name | City | State |
---|---|---|---|
France | Centre Régional Metz-Thionville | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Convergent validity | PRO-CTCAE The convergent validity will be evaluated by the correlation between the QuestOnco and the weekly paper form of the PRO-CTCAE questionnaire. PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE) External Web Site Policy, the standard lexicon for adverse event reporting in cancer clinical trials. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4 (minimum/maximum). |
At the end of study completion (Week 6) | |
Secondary | Patients' comprehension of QuestOnco application items | Semi-structured cognitive interviews: Interviews will be conducted to evaluate patients' comprehension of the QuestOnco application items. Items will be modified and restested if more than 2 patients manifest cognitive difficulties. The item modifications will be conducted during focus groups gathering experts including Emergency department practitioners, General practitioner, Oncologists, Pharmacists, and Methodologists. This procedure will be repeated 3 times a maximum for a total of 30 patients. |
At the end of the study completion: Phase I (Day 7) | |
Secondary | The known-groups validity assessment | The known-groups validity will be assessed by comparing the QuestOnco items between patients with high and low performance status using the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 vs 2-4 (minimum vs maximum). | At the end of the study completion (Week 6) | |
Secondary | Evaluation of the efficacy of the QuestOnco application in patient care | Calculation of the time spent (minutes) in consultation with the Oncologist using QuestOnco application fill form | At the end of study completion (Week 6) | |
Secondary | Evaluation of the responsiveness of the QuestOnco application in patient care | Calculation of the number (percent) of appointments actually realized using QuestOnco application fill form | At the end of the study completion (Week 6) | |
Secondary | The reliability of the QuestOnco application in patient care | Calculation of the number (percent) of the automatic telephone alert calls to the regional Emergency service using QuestOnco application fill form | At the end of the study completion (Week 6) | |
Secondary | Synchronization of departments (Emergency division, Oncology team) and patients' care | Calculation of the number (percent) of scheduled consultation based on the statement of reported-toxicity score (symptom severity from grades II to IV) of cancer patients using electronic mobile QuestOnco application. | At the end of the study completion (Week 6) | |
Secondary | Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application | The patients' quality of life will be assessed using EORTC QLC-QC30 questionnaire The EORTC QLQ-C30 is a 30-item core-cancer-specific questionnaire-integrating system for assessing the health-related QOL of cancer patients participating in international clinical trials. The questionnaire incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of two items in the global health/QOL scale which use modified 7-point linear analog scales. | At the end of the study completion (Week 1 and 6) |
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 |
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 |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|