DistressWINNCT01849523
Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study
A study testing Web-based information and support in people with Distress and Quality of Life, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress, Quality of Life, Neuroendocrine Tumor
- What is being tested?
- Web-based information and support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Estimated life expectancy less than 3 months.
- Patients with a second primary tumor for which active follow-up or treatment.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medical Spectrum Twente
Enschede
University Medical Center Groningen
Groningen, 9713 GZ
About this study
Official title: 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.
Read more
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.
- Conditions
- Distress, Quality of Life, Neuroendocrine Tumor
- Being tested
- Web-based information and support
- Keywords
- Neuroendocrine tumor, Website, Information, Psychosocial support
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based information and supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Web-based information and support | Experimental | Web-based tailored information and support Receives: Behavioral: Web-based information and support |
| Standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To test whether patients experience less distress after having received web-based tailored information and support.
Measured: 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.
Measured: 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.
Measured: 14 weeks. This is the period a patient can use the website, thereafter a end-of study questionnaire will be filled out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A.M.E. Walenkamp, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849523
- Sponsor's protocol ID
- Pilot WIN-2013
- Other IDs
- NL43834.042.13
- Acronym
- WIN
- Status last verified
- May 2024
- First submitted
- 3 May 2013
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28185086
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study (Pilot WIN-study).
- ClinicalTrials.gov ID
- NCT01849523
- Acronym / sponsor ID
- WIN / Pilot WIN-2013
- Conditions
- Distress, Quality of Life, Neuroendocrine Tumor
- Keywords
- Neuroendocrine tumor, Website, Information, Psychosocial support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based information and support | Experimental | Behavioral: Web-based information and supportWeb-based tailored information and support |
| Standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Estimated life expectancy less than 3 months.
- Patients with a second primary tumor for which active follow-up or treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based information and support | Behavioural | Web-based information and support |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 28185086Bouma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.M.E. Walenkamp, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based information and support in people with Distress and Quality of Life, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.