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van CCT (UK)

van CCT (UK)

Effect evaluation of the online application Oncokompas.

- candidate number29574
- NTR NumberNTR7494
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2018
- Secondary IDs2018.224  METc VUmc
- Public TitleEffect evaluation of the online application Oncokompas.
- Scientific TitleEfficacy and cost-utility of the eHealth application 'Oncokompas' for patients with incurable cancer.
- hypothesisThe main hypothesis is that use of Oncokompas will be superior to care as usual to improve patient activation, self-efficacy and quality of life, and it is expected that Oncokompas will improve quality-adjusted life years (QALYs) at acceptable costs compared to care-as-usual.
- Healt Condition(s) or Problem(s) studiedCancer, Incurable cancer
- Inclusion criteria- Incurable cancer; no curative treatment options;
- Diagnosed with lung cancer, breast cancer, colorectal cancer, head and neck cancer, lymphoma or glioma;
- A prognosis of at least 3 months;
- Awareness of the incurability of the cancer.
- Exclusion criteria- Not having access to the internet and not having an e-mail address;
- Severe cognitive impairments;
- Psychotic behavior (delusions and hallucinations);
- Poor understanding of the Dutch language (and thereby not able to complete a Dutch questionnaire);
- Younger than 18 years;
- Patients too ill to participate;
- Not willing to participate;
- No informed consent;
- Patients who participated in the randomized controlled trial of the ICT4CANCER project (as a cancer survivor), but who are now diagnosed with incurable cancer;
- E-mail address of patient is already registered in Oncokompas (this means that a patient is familiar with using Oncokompas);
- A patient of which his/her physician thinks participation in another study will be too much of a burden for this particular patient (because this patient is also participating in other studies).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2018
- planned closingdate1-okt-2019
- Target number of participants136
- InterventionsAccess to the eHealth self-management application Oncokompas.
- Primary outcomePatient Activation Measure (PAM)
- Secondary outcomeGeneral Self-Efficacy, health related quality of life, costs
- TimepointsT0 - baseline
T1 - 2 week follow-up
T2 - 3 months follow-up
- Trial web site-
- statusplanned
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summaryBackground: Each year over 40.000 patients die of cancer. Although discussing palliative care options in time significantly improves quality of life of patients, this often occurs at a late stage of the advanced cancer trajectory. Patients with incurable cancer often have unmet informational and care needs and are uncertain where they can go for advice and guidance. Nowadays it is expected that patients adopt an active role in the management of their own care to improve the access to palliative care. Since the past decades there is a growing interest in self-management and eHealth as means to improve (the access to) care. Research shows that patients benefit from self-management interventions in terms of patient activation and self-efficacy. An eHealth self-management application monitoring the quality of life and providing personalized advice and guidance to palliative care services, could be a solution to meet the palliative care needs of individual patients with incurable cancer.
Methods: A multi center prospective randomized controlled trial with two parallel groups will be conducted. Patients are randomly assigned to either the intervention condition, direct access to Oncokompas, or the waiting list condition receiving care-as-usual. 136 adult patients with incurable cancer (lung cancer, breast cancer, colorectal cancer, head and neck cancer, lymphoma or glioma), who no longer have curative treatment options and face a prognosis of at least 3 months, will be included. Participants will be asked to complete a questionnaire at the time of inclusion (t0), 2 weeks after randomization (t1) and at 3 months follow-up (t2). The primary outcome is patient activation (PAM). Secondary outcomes are general self-efficacy (GSE) and quality of life (EORTC QLQ-C15-PAL). To investigate the cost-utility we will use different cost questionnaires (iMCQ and iPCQ) and the EQ-5D. Patients randomized into the control group will have access to Oncokompas after 3 months.
- Main changes (audit trail)
- RECORD24-sep-2018 - 6-okt-2018

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