Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597240
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-01-17
Brief Title:
Home Monitoring During Chemoradiation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
At-home Monitoring of Patients During Chemoradiation for Locally Advanced Head and Neck Cancer the AMCOR Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMCOR
Brief Summary:
Chemoradiotherapy is part of standard treatment for patients with locally advanced head and neck cancer Some patients with head and neck cancer treated with chemoradiotherapy do not complete treatment due to toxicity or face complications after treatment Therefore there is a need for better tools for assessing patients fitness for chemoradiotherapy and to pick up early signals of deteriorating overall physical condition and complications during and after treatment to timely implement supportive care measures Tools enabling monitoring physical activity vital parameters and creatinine concentration in the blood at home are available but have not yet been implemented in patients undergoing chemoradiotherapy for head and neck cancer The feasibility and added value remain unknown
Detailed Description:
This is an observational feasibility study in which 30 ambulant patients with head and neck cancer are continuously monitored from 1 week before chemoradiation until 3 weeks after chemoradiation for head and neck cancer in addition to standard care
We provide them with a monitoring kit of Siemens and a finger prick test of Nova Biomedical
The monitoring kit of Siemens Healthineers contains multiple measuring tools including
a blood pressure measuring device which will be applied to the upper arm
an oxygen saturation measuring device which will also measure the pulse when applied to the fingertip
a scale which will measure body weight
a skin thermometer which will detect body temperature
An activity trackerwatch which will measure every step taken during the day when worn around the wrist by the participant All measurements will be automatically send to the online portal which can be seen by the investigators
Participants will receive a dedicated smartphone with an application to monitor their measurements at home for the duration of their study participation The telephone does not provide any other functions than the specific app function
With a finger stick test participants will measure the creatinine level in the blood Nova Max Pro Creat Meter is a handheld analyser and miniaturized single-use biosensor for whole blood creatinine testing It enables assessment of renal function by fingerstick capillary blood sampling at home It uses 12 μL capillary blood and shows the result in 30 seconds on the screen in μmolL The patient will carry out this measurement once a week the day before routine blood testing in the hospital The values are transferred to the app via a Bluetooth connection
We will collect information on quality of life QoL and taste before during and after treatment using a Quality of Life Questionnaire QLQ and a taste questionnaire For QoL we will use the validated questionnaires of the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 the core instrument that consists of 30 questions and the QLQ-OES18 the oesophageal cancer module that consists of 18 questions The QLQ-OES18 consists of four scales ie dysphagia eating reflux and pain and six single items being swallowing saliva choking when swallowing dry mouth taste problems coughing and speech problems The QLQ-C30 questionnaire consists 30 items and questions the overall global health statusQoL score with the use of five functioning scores physical role emotional cognitive and social functioning and three composite symptom scores fatigue nausea and vomiting Six single-symptom items are also assessed being pain dyspnea insomnia appetite loss constipation and diarrhea The overall global health status and overall QoL score uses a seven-point Likert scale ranging from very poor to excellent and the remaining items in the EORTC use a four-point Likert scale ranging from not at all to very much These scale scores are linearly converted to a 0-100 scale where higher scores of the functioning scores and global QoL reflect higher levels of functioning and for the symptom scales higher scores reflect higher levels of symptom burden Patients who reported a little change for better or worse on a particular scale function or symptom had QLQ-C30 changes about 5 to 10 Those reporting moderate change had changed about 10 to 20 and very much change corresponded to a change greater than 20 A difference of 10 points up or down is often chosen as a clinically significant difference
Taste will be assessed with the Chemotherapy-induced Taste Alteration Scale CiTAS This validated questionnaire consists of 18 questions with a Likert scale 1 to 5 where 1 no difficulty or absence of the disturbance and 5 maximum difficulty or disturbance It was developed based on semi-structured interviews with eight patients with cancer undergoing chemotherapy and is the first validated questionnaire regarding taste changes available in many languages It evaluates four dimensions of taste alterations intensity of taste discomfort phantogeusie and parageusia and general alterations of taste The final score can be calculated by dividing the total score by the number of questions per section or in total which gives an aim of the severity of the taste changes
We provide them with a monitoring kit of Siemens and a finger prick test of Nova Biomedical
The monitoring kit of Siemens Healthineers contains multiple measuring tools including
a blood pressure measuring device which will be applied to the upper arm
an oxygen saturation measuring device which will also measure the pulse when applied to the fingertip
a scale which will measure body weight
a skin thermometer which will detect body temperature
An activity trackerwatch which will measure every step taken during the day when worn around the wrist by the participant All measurements will be automatically send to the online portal which can be seen by the investigators
Participants will receive a dedicated smartphone with an application to monitor their measurements at home for the duration of their study participation The telephone does not provide any other functions than the specific app function
With a finger stick test participants will measure the creatinine level in the blood Nova Max Pro Creat Meter is a handheld analyser and miniaturized single-use biosensor for whole blood creatinine testing It enables assessment of renal function by fingerstick capillary blood sampling at home It uses 12 μL capillary blood and shows the result in 30 seconds on the screen in μmolL The patient will carry out this measurement once a week the day before routine blood testing in the hospital The values are transferred to the app via a Bluetooth connection
We will collect information on quality of life QoL and taste before during and after treatment using a Quality of Life Questionnaire QLQ and a taste questionnaire For QoL we will use the validated questionnaires of the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 the core instrument that consists of 30 questions and the QLQ-OES18 the oesophageal cancer module that consists of 18 questions The QLQ-OES18 consists of four scales ie dysphagia eating reflux and pain and six single items being swallowing saliva choking when swallowing dry mouth taste problems coughing and speech problems The QLQ-C30 questionnaire consists 30 items and questions the overall global health statusQoL score with the use of five functioning scores physical role emotional cognitive and social functioning and three composite symptom scores fatigue nausea and vomiting Six single-symptom items are also assessed being pain dyspnea insomnia appetite loss constipation and diarrhea The overall global health status and overall QoL score uses a seven-point Likert scale ranging from very poor to excellent and the remaining items in the EORTC use a four-point Likert scale ranging from not at all to very much These scale scores are linearly converted to a 0-100 scale where higher scores of the functioning scores and global QoL reflect higher levels of functioning and for the symptom scales higher scores reflect higher levels of symptom burden Patients who reported a little change for better or worse on a particular scale function or symptom had QLQ-C30 changes about 5 to 10 Those reporting moderate change had changed about 10 to 20 and very much change corresponded to a change greater than 20 A difference of 10 points up or down is often chosen as a clinically significant difference
Taste will be assessed with the Chemotherapy-induced Taste Alteration Scale CiTAS This validated questionnaire consists of 18 questions with a Likert scale 1 to 5 where 1 no difficulty or absence of the disturbance and 5 maximum difficulty or disturbance It was developed based on semi-structured interviews with eight patients with cancer undergoing chemotherapy and is the first validated questionnaire regarding taste changes available in many languages It evaluates four dimensions of taste alterations intensity of taste discomfort phantogeusie and parageusia and general alterations of taste The final score can be calculated by dividing the total score by the number of questions per section or in total which gives an aim of the severity of the taste changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None