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

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ClinicalTrials.gov Identifier: NCT01849523
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Distress Quality of Life Neuroendocrine Tumor Behavioral: Web-based information and support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study (Pilot WIN-study).
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-based information and support
Web-based tailored information and support
Behavioral: Web-based information and support
No Intervention: Standard care
Standard care



Primary Outcome Measures :
  1. detect an improvement in perception and satisfaction of the received information [ Time Frame: 14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out ]
    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.


Secondary Outcome Measures :
  1. Distress level after receiving information [ Time Frame: 14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out ]
    To test whether patients experience less distress after having received web-based tailored information and support.

  2. Quality of life [ Time Frame: 14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out ]
    To test whether patients experience a higher quality of life after receiving web-based tailored information and support.

  3. Empowerment enhancement [ Time Frame: 14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out ]
    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.



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Ages Eligible for Study:   18 Years and older   (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 with a second primary tumor for which active follow-up or treatment.

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): NCT01849523


Locations
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Netherlands
Medical Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: A.M.E. Walenkamp, MD, PhD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A.M.E. Walenkamp, Principal Investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01849523     History of Changes
Other Study ID Numbers: Pilot WIN-2013
NL43834.042.13 ( Other Identifier: ABR number CCMO )
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014

Keywords provided by A.M.E. Walenkamp, University Medical Center Groningen:
Neuroendocrine tumor
Website
Information
Psychosocial support

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