Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- A composite outcome of difference in distress and the mean improvement of the global score of the EORTC QLQ-INFO 25
Study Overview
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.
Detailed Description
Rationale: 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 invetigators expect that the website is a highly suitable medium to provide tailored information and support.
Objective: This study has a combined objective to investigate whether a web-based tailored information and support system reduces distress, as determined by a decrease in value of the distress thermometer, and/or improves patients' perception and satisfaction of received information, as determined by an improved score at the EORTC QLQ-INFO 25 questionnaire, as compared to patients who receive standard care.
Secondary aims are improvement in quality of life as determined by the cancer-specific EORTC QLQ-C30 and the NET-specific EORTC QLQ-GINET21, empowerment at end of study (subscales of the Construct Empowering Outcomes questionnaire) and to investigate patients' opinion about and use of the web-based tailored information and support system (with a self-constructed questionnaire; based on constructs of the Technology Acceptance Model (TAM) questionnaire and two self-constructed questions).
Study design: The present study is a single center randomized, prospective, intervention study on the efficacy of a tailored web-based information and support system in NET patients. After randomization and stratification - based on the time from diagnosis till inclusion- the control group receives standard care and the experimental group receives the standard care complemented with use of the web-based tailored information and support system for 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Arms & Interventions
Standard care
The control group will receive standard care.
Intervention: Standard care (Other)
Experimental group
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)
Intervention: Web-based tailored information and support system (Other)
Outcomes
Primary Outcomes
A composite outcome of difference in distress and the mean improvement of the global score of the EORTC QLQ-INFO 25
Time Frame: 12 weeks
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.
Secondary Outcomes
- change in quality of life,(12 weeks)
- Information about patients' opinion and use of the web-based tailored information and support system(12 weeks)
- Empowerment at end of study(12 weeks)