Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study
WIN
2 other identifiers
interventional
20
1 country
2
Brief Summary
Background Physical as well as psychosocial complaints are frequently present in patients with a neuroendocrine tumor (NET). Adequate information is seen as an essential aspect of supportive care. The aim of the current study is to test the effectiveness of a web-based tailored information and support system targeting patients' information and care needs. Key features of this system are self-screening of physical and psychosocial problems, tailored education on reported problems and self-referral to professional health care. Objective To detect whether a web-based tailored information and support system improves patients' perception and satisfaction of received information. The investigators hypothesize that after having received web-based tailored information and support patients feel more informed and are more satisfied with the received information than when receiving standard care. Study design The present study is a randomized prospective longitudinal experimental multicenter pilot study. In this study, we want to examine the effect sizes on the perception and satisfaction by the patient of received information (primary objective) and secondary objectives after having used web-based tailored information and support. Eligible are newly diagnosed NET-patients (N=40) (diagnosed less than 3 months ago). Patients will be asked to fill out questionnaires at baseline and after 12 weeks, on socio-demographic features (only at baseline), internet use (only at baseline), health care use, patients' perception and satisfaction of received information, distress, quality of life and empowerment (only after 12 weeks). Study population Patients diagnosed with a NET (any type of NET, any phase of disease) who are under treatment at the Department of Medical Oncology in the University Medical Center Groningen or Hospital Medisch Spectrum; twenty will be invited to participate in the study. Intervention During 12 subsequent weeks, a personalized website (with a surname/password) will become available to patients in the experimental group beside the usual standard care. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive automated feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, options for (self)-help and possibilities for referral to professional care. Contact information will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call. Main study endpoint The primary endpoint is to detect an improvement in patients' perception and satisfaction of received information after having received web-based tailored information and support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 8, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 6, 2024
May 1, 2024
10 months
May 3, 2013
May 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
detect an improvement in perception and satisfaction of the received information
The primary objective is to detect an improvement in perception and satisfaction of the received information by NET-patients after having used the online tailored information and support system. We hypothesize that patients perceive to have received more information and are more satisfied with the received information after having used the web-based tailored information and support system.
14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Secondary Outcomes (3)
Distress level after receiving information
14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Quality of life
14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Empowerment enhancement
14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Study Arms (2)
Web-based information and support
EXPERIMENTALWeb-based tailored information and support
Standard care
NO INTERVENTIONStandard care
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Estimated life expectancy less than 3 months.
- Patients with a second primary tumor for which active follow-up or treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Related Publications (1)
Bouma G, de Hosson LD, van Woerkom CE, van Essen H, de Bock GH, Admiraal JM, Reyners AKL, Walenkamp AME. Web-based information and support for patients with a newly diagnosed neuroendocrine tumor: a feasibility study. Support Care Cancer. 2017 Jul;25(7):2075-2083. doi: 10.1007/s00520-017-3598-7. Epub 2017 Feb 9.
PMID: 28185086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A.M.E. Walenkamp, MD, PhD
University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2013
First Posted
May 8, 2013
Study Start
October 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 6, 2024
Record last verified: 2024-05