Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424054
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-09
Brief Title:
Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects
Sponsor:
Noordwest Ziekenhuisgroep
Organization:
Noordwest Ziekenhuisgroep
Study Overview
Official Title:
Mitigating Toxicity of NeoAdjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects the Prospective Randomized eChemoCoach Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eChemoCoach
Brief Summary:
Chemotherapy induces side effects varying in severity impacting patients quality of life and necessitating unplanned hospital care Patient-reported outcomes PROs could aid in early detection and management of side effects However existing PRO monitoring lacks triage capabilities leading to clinician involvement and suboptimal symptom management The investigators propose eChemoCoach an electronic questionnaire integrated into the electronic health portal offering real-time symptom assessment and personalized advice based on CTCAE criteria Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE 3 graded side effects in early breast cancer patients undergoing chemotherapy This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoachs efficacy compared to standard monitoring Phase one will validate questionnaires and assess usability while phase two focuses on the primary outcome Te investigators anticipate reduced severe side effects thereby enhancing patients quality of life reducing stress and minimizing hospital visits
Detailed Description:
Problem description The aim of neoadjuvant chemotherapy is to increase survival Therefore treatment adherence is important However patients may experience treatment-related side-effects In current practice clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity increase treatment adherence and reduce the decline in quality of life Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity Therefore patients should receive a direct advice when experiencing side-effects However without interference of a health care professional this is not possible in standard care
Solution research direction There is increasing evidence that incorporating patient reported outcomes PROs in clinical care enhances symptom monitoring in cancer patients Therefore it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which 1 delivers a real-time personalized advice to the patient based on CTCAE grading after the questionnaire is completed and 2 is accessible for patients using an electronic health portal EHP of the electronic health record EHR to integrate the PRO data into the EHR
Aim hypothesis To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects on the occurrence of CTCAE grade 3 toxicity
Plan of investigation To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire Thereafter a multicenter clinical randomized trial will start where patients with breast cancer qualifying for neoadjuvant chemoimmunetherapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring or to standard of care monitoring solely Primary objective is the overall rate of CTC grade 3 non hematological toxicity between both arms Secondary objectives include relative dose intensity health-related quality of life experienced distress the number of unplanned health care usage and costs
Expected outcome The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade 3 non-hematological toxicities
Solution research direction There is increasing evidence that incorporating patient reported outcomes PROs in clinical care enhances symptom monitoring in cancer patients Therefore it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which 1 delivers a real-time personalized advice to the patient based on CTCAE grading after the questionnaire is completed and 2 is accessible for patients using an electronic health portal EHP of the electronic health record EHR to integrate the PRO data into the EHR
Aim hypothesis To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects on the occurrence of CTCAE grade 3 toxicity
Plan of investigation To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire Thereafter a multicenter clinical randomized trial will start where patients with breast cancer qualifying for neoadjuvant chemoimmunetherapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring or to standard of care monitoring solely Primary objective is the overall rate of CTC grade 3 non hematological toxicity between both arms Secondary objectives include relative dose intensity health-related quality of life experienced distress the number of unplanned health care usage and costs
Expected outcome The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade 3 non-hematological toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None