Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02472678
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-01-06
Brief Title:
Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor
Status:
COMPLETED
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:
WIN
Brief Summary:
Patients with a neuroendocrine tumor NET frequently suffer from physical as well as psychosocial complaints Patients may experience various symptoms from tumor burden and secreted hormones by the tumor They also can have complaints due to their anti-cancer treatment and accompanying side effects
Adequate information is an essential aspect of supportive care Patients need for information and care remain frequently unnoticed The aim of the current study is to test the effectiveness of a web-based tailored information and support system to support patients information and care needs Key features of this website are patient self-screening of physical and psychosocial problems tailored patient education on reported problems and self-referral to professional health care The investigators expect that the website is a highly suitable medium to provide tailored information and support
Adequate information is an essential aspect of supportive care Patients need for information and care remain frequently unnoticed The aim of the current study is to test the effectiveness of a web-based tailored information and support system to support patients information and care needs Key features of this website are patient self-screening of physical and psychosocial problems tailored patient education on reported problems and self-referral to professional health care The investigators expect that the website is a highly suitable medium to provide tailored information and support
Detailed Description:
Rationale Patients with a neuroendocrine tumor NET frequently suffer from physical as well as psychosocial complaints Patients may experience various symptoms from tumor burden and secreted hormones by the tumor They also can have complaints due to their anti-cancer treatment and accompanying side effects
Adequate information is an essential aspect of supportive care Patients need for information and care remain frequently unnoticed The aim of the current study is to test the effectiveness of a web-based tailored information and support system to support patients information and care needs Key features of this website are patient self-screening of physical and psychosocial problems tailored patient education on reported problems and self-referral to professional health care The invetigators expect that the website is a highly suitable medium to provide tailored information and support
Objective This study has a combined objective to investigate whether a web-based tailored information and support system reduces distress as determined by a decrease in value of the distress thermometer andor improves patients perception and satisfaction of received information as determined by an improved score at the EORTC QLQ-INFO 25 questionnaire as compared to patients who receive standard care
Secondary aims are improvement in quality of life as determined by the cancer-specific EORTC QLQ-C30 and the NET-specific EORTC QLQ-GINET21 empowerment at end of study subscales of the Construct Empowering Outcomes questionnaire and to investigate patients opinion about and use of the web-based tailored information and support system with a self-constructed questionnaire based on constructs of the Technology Acceptance Model TAM questionnaire and two self-constructed questions
Study design The present study is a single center randomized prospective intervention study on the efficacy of a tailored web-based information and support system in NET patients After randomization and stratification - based on the time from diagnosis till inclusion- the control group receives standard care and the experimental group receives the standard care complemented with use of the web-based tailored information and support system for 12 weeks
Patients will be asked to fill out questionnaires at baseline and after 12 weeks
Patients in the intervention group are asked to fill out an extra questionnaire about use of the web-based tailored information and support system
Study population Diagnosed NET patients who are under treatment at the Department of Medical Oncology in the University Medical Center Groningen will be invited to participate in the study The investigators will stratify for newly diagnosed patients diagnosed within six months before inclusion and patients diagnosed more than 6 months before inclusion
Adequate information is an essential aspect of supportive care Patients need for information and care remain frequently unnoticed The aim of the current study is to test the effectiveness of a web-based tailored information and support system to support patients information and care needs Key features of this website are patient self-screening of physical and psychosocial problems tailored patient education on reported problems and self-referral to professional health care The invetigators expect that the website is a highly suitable medium to provide tailored information and support
Objective This study has a combined objective to investigate whether a web-based tailored information and support system reduces distress as determined by a decrease in value of the distress thermometer andor improves patients perception and satisfaction of received information as determined by an improved score at the EORTC QLQ-INFO 25 questionnaire as compared to patients who receive standard care
Secondary aims are improvement in quality of life as determined by the cancer-specific EORTC QLQ-C30 and the NET-specific EORTC QLQ-GINET21 empowerment at end of study subscales of the Construct Empowering Outcomes questionnaire and to investigate patients opinion about and use of the web-based tailored information and support system with a self-constructed questionnaire based on constructs of the Technology Acceptance Model TAM questionnaire and two self-constructed questions
Study design The present study is a single center randomized prospective intervention study on the efficacy of a tailored web-based information and support system in NET patients After randomization and stratification - based on the time from diagnosis till inclusion- the control group receives standard care and the experimental group receives the standard care complemented with use of the web-based tailored information and support system for 12 weeks
Patients will be asked to fill out questionnaires at baseline and after 12 weeks
Patients in the intervention group are asked to fill out an extra questionnaire about use of the web-based tailored information and support system
Study population Diagnosed NET patients who are under treatment at the Department of Medical Oncology in the University Medical Center Groningen will be invited to participate in the study The investigators will stratify for newly diagnosed patients diagnosed within six months before inclusion and patients diagnosed more than 6 months before inclusion
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