Trial record 9 of 16 for: walenkamp

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

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ClinicalTrials.gov Identifier: NCT02472678

Recruitment Status : Completed

First Posted : June 16, 2015

Last Update Posted : May 5, 2017

Sponsor:

Information provided by (Responsible Party):

A.M.E. Walenkamp, University Medical Center Groningen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neuroendocrine Tumor	Other: Web-based tailored information and support system Other: Standard care	Not Applicable

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, 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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	91 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor
Study Start Date :	May 2015
Actual Primary Completion Date :	May 2017
Actual Study Completion Date :	May 2017

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Standard care The control group will receive standard care.	Other: Standard care The control group will receive standard care.
Experimental: Experimental group In addition to standard care, the experimental group will be given access to the web-based tailored information and support system (with a username/password)	Other: Web-based tailored information and support system Access to the web-based tailored information and support system (with a username/password)

Outcome Measures

Primary Outcome Measures :

A composite outcome of difference in distress and the mean improvement of the global score of the EORTC QLQ-INFO 25 [ Time Frame: 12 weeks ]
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.

Secondary Outcome Measures :

change in quality of life, [ Time Frame: 12 weeks ]
change in quality of life as determined by the cancer-specific EORTC QLQ-C30, and the EORTC QLQ-GINET21,
Empowerment at end of study [ Time Frame: 12 weeks ]
empowerment at end of study (subscales of the Construct Empowering Outcomes questionnaire)
Information about patients' opinion and use of the web-based tailored information and support system [ Time Frame: 12 weeks ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472678

Locations

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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Center Groningen

Investigators

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Principal Investigator:	A. M.E. Walenkamp, MD, PhD	University Medical Center Groningen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de Hosson LD, Bouma G, Stelwagen J, van Essen H, de Bock GH, de Groot DJA, de Vries EGE, Walenkamp AME. Web-based personalised information and support for patients with a neuroendocrine tumour: randomised controlled trial. Orphanet J Rare Dis. 2019 Feb 28;14(1):60. doi: 10.1186/s13023-019-1035-3.

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Responsible Party:	A.M.E. Walenkamp, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier:	NCT02472678 History of Changes
Other Study ID Numbers:	20150501
First Posted:	June 16, 2015 Key Record Dates
Last Update Posted:	May 5, 2017
Last Verified:	May 2017

Additional relevant MeSH terms:

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Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue

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