The goal of this study is to investigate the efficacy and cost-utility of Oncokompas among patients with incurable cancer compared to care-as-usual. The main hypothesis is that use of Oncokompas will be superior to care as usual to improve patient…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
oncologische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measue is patient activation (PAM).
Secondary outcome
Secondary outcomes are general self-efficacy (GSE), 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.
Background summary
Each year over 40.000 patients die of cancer. Although discussing palliative
care options improves quality of life in patients, this often often occurs at a
late stage of the advanced cancer trajectory. 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 has shown 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.
Study objective
The goal of this study is to investigate the efficacy and cost-utility of
Oncokompas among patients with incurable cancer compared to care-as-usual.
The 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.
Furthermore, a qualitative follow-up study (PAMQOL-study) will be conducted to
explore to which extent patients feel activated by using the online
self-management tool Oncokompas and which role they think Oncokompas plays in
their health-related activities.
Study design
A monocenter prospective randomized controlled trial with two parallel groups.
Patients are randomly assigned to either the intervention condition, direct
access to Oncokompas, or the waiting list condition receiving care-as-usual.
The PAMQOL-study will be a qualitative study among patients who participated in
the RCT and gave their consent that they could be approached for follow-up
research regarding Oncokompas.
Intervention
The intervention investigated in this study is the online self-management
application Oncokompas. Oncokompas is an integrated eHealth self-management
application to monitor the different domains of quality of life and to provide
personalized information on quality of life to patients. Oncokompas supports
patients in finding optimal supportive care, adjusted to their quality of life
and personal preferences.
In this study, care-as-usual is defined as care provided by the oncological
team or by other health care professionals and includes all medical and
supportive care that patients receive regardless of their participation in this
study.
Study burden and risks
The main burden for participants is to fill in the questionnaires for the
study. Participants will be asked to fill in questionnaires at three moments in
time. Patients in the intervention group will also spend time on using
Oncokompas.
Risks are negligible. In case of positive results, participating patients will
probably benefit immediately from the online self-management application.
The interviews of the PAMQOL-study will take up to an hour of the participants'
time to minimize the burden for participants.
de Boelelaan 1
Amsterdam 1081 BT
NL
de Boelelaan 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria of the RCT:
- Incurable cancer; no curative treatment options;
- A prognosis of at least 3 months;
- Awareness of the incurability of the cancer.
Additional criteria of the PAMQOL-study:
For the qualitative study additional inclusion criteria are that a patient must
have completed the RCT and gave his/her permission on the informed consent form
of the RCT that he/she could be approached for the follow-up study.
Exclusion criteria
- Not having access to the internet and not having an e-mail address;
- Severe cognitive impairments;
- Psychotic behaviour (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 this patient is familiar with using Oncokompas);
- Patients of which their physician/nurse thinks participation in another study
will be too much of a burden.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66307.029.18 |