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

Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study (Pilot WIN-study).

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Distress; Neuroendocrine Tumor
• Intervention / Treatment: Behavioral: Web-based information and support

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands
    • Medical spectrum Twente
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 with a second primary tumor for which active follow-up or treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Web-based information and support; Web-based tailored information and support	Behavioral: Web-based information and support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress level after receiving information	To test whether patients experience less distress after having received web-based tailored information and support.	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	To test whether patients experience a higher quality of life after receiving web-based tailored information and support.	14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Empowerment enhancement	To examine whether a web-based tailored information and support system enhances empowerment within the meaning of being better informed, feeling more confident in the relationship with their physician, improved acceptance of the illness, feeling more confident about the treatment and increased optimism and control over the future.	14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimated): May 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Website; Psychosocial support; Neuroendocrine tumor; Information
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: Pilot WIN-2013; NL43834.042.13 (Other Identifier: ABR number CCMO)