Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor

Neuroendocrine Tumor Clinical Trial

— WIN  

Official title:

Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472678
• Other study ID #: 20150501
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: May 4, 2017
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, and/or 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult NET patients (aged = 18 years of age) with any tumor site and disease stage.

• Ability to comprehend Dutch (both reading and writing).

• Informed consent provided

Exclusion Criteria:

• Estimated life expectancy less than 3 months.

• Patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for = 3 years

• Patients who participated in the WIN-pilot study.

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Other:
• Web-based tailored information and support system
Access to the web-based tailored information and support system (with a username/password)
• Standard care
The control group will receive standard care.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite outcome of difference in distress and the mean improvement of the global score of the EORTC QLQ-INFO 25	The primary endpoint is a composite of the difference in distress measured by the distress thermometer and the mean improvement of the global score of the EORTC QLQ-INFO 25 at end of study between the control group and the intervention group.	12 weeks
Secondary	change in quality of life,	change in quality of life as determined by the cancer-specific EORTC QLQ-C30, and the EORTC QLQ-GINET21,	12 weeks
Secondary	Empowerment at end of study	empowerment at end of study (subscales of the Construct Empowering Outcomes questionnaire)	12 weeks
Secondary	Information about patients' opinion and use of the web-based tailored information and support system	investigation of 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	12 weeks