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Development and evaluation of an online platform for advanced cancer patients who obtain durable response to immunotherapy or targeted therapy in co-creation with patients, psychologists and service providers.

Development and evaluation of an online platform for advanced cancer patients who obtain durable response to immunotherapy or targeted therapy in co-creation with patients, psychologists and service providers. - IMPRESS platform

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56652
Enrollment
57
Registered
2024-03-19
Start date
2024-05-07
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

distress symptoms Psychological distress

Interventions

None listed

Sponsors

Universiteit van Tilburg
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients are diagnosed with stage IV cancer with confirmed response to or long-term stable disease while on immunotherapy or targeted therapy. We consider a response confirmed after the second scan shows that patients respond well (i.e. RECIST at least partial response or >1 year of stable disease) to one of both therapies.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
The aim of this study is to develop and evaluate an online platform for advanced cancer patients who obtain durable response to IT or TT in co-creation with patients, psychologists and service providers. Endpoints will be studied in the evaluation phase. We will examine the feasibility of the platform by assessing patients* usage of the platform during the first month they gained access to it. We will assess login frequency and activity on the platform using Google Analytics. Frequency refers to the number of visits per patient during the 1-month period of access to the platform. Activity refers to the number of opened ingredients (information, tasks, tests, videos) per patient. We will assess usability (i.e. the appropriateness of the platform to its purpose) via a self-reported outcome, the so-called System Usability Scale (SUS), which has often been used to assess the usability of websites and categorizes them as either poor, okay, good or excellent. This gives an indication of how easy to use and satisfactory the platform is and how likely patients are to return. Moreover, we will assess the extent to which the information and content by employing a custom made questionnaire. This questionnaire will inquire about the coverage of essential topics relevant to patients within the platform. We will track how many people who meet the eligibility criteria and are referred to the study by healthcare professionals and how many of them want to participate in the study and test the platform. Qualitative semi-structured interviews will provide us with additional information about experiences of patients (and potentially of their close others) with using the platform, and if so, how it was helpful to them.

Secondary

MeasureTime frame
In order to examine the effects of utilizing the platform, participants will be required to fill out baseline and follow-up questionnaires related to their levels of anxiety, depressive symptoms, and resilience. Anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale, containing 14 items. Resilience will be measured with the Brief Resilience Scale, which consists of 6 items exploring the extent to which patients in general quickly recover from adverse events.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)