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

NCT02472678 | Completed

• 1 other identifier: 20150501
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in quality of life,

  12 weeks

• Empowerment at end of study

  12 weeks

• Information about patients' opinion and use of the web-based tailored information and support system

  12 weeks

Study Arms (2)

Standard care

OTHER

The control group will receive standard care.

Other: Standard care

Experimental group

EXPERIMENTAL

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

Interventions

Web-based tailored information and support system OTHER

Access to the web-based tailored information and support system (with a username/password)

Experimental group

Standard care OTHER

The control group will receive standard care.

Standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30819238 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• A. M.E. Walenkamp, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: June 16, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

NL (1)