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Effect evaluation of Oncokompas 2.0.


- candidate number24094
- NTR NumberNTR5774
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-mrt-2016
- Secondary IDs2015.523 METc VUmc
- Public TitleEffect evaluation of Oncokompas 2.0.
- Scientific TitleEfficacy and cost-utility of Oncokompas 2.0, a self-management eHealth application for cancer survivors.
- ACRONYM-
- hypothesisThe use of Oncokompas2.0 will be superior to care as usual regarding self-efficacy, patient empowerment and costs.
- Healt Condition(s) or Problem(s) studiedCancer, Cancer patients
- Inclusion criteriaPatients diagnosed with breast, colorectal, head and neck cancer or lymphoma, age ≥ 18 years (no upper limit), 3 months – 5 years after treatment with curative intent (all treatment modalities) and with accessibility to the internet.
- Exclusion criteriaSevere cognitive impairment, insufficient mastery of Dutch language, or insufficient basic internet skills.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate1-apr-2018
- Target number of participants544
- InterventionsAccess to Oncokompas 2.0.
- Primary outcomePatient Activation Measure (PAM)
- Secondary outcomeSelf efficacy, patient empowerment, need for supportive care, mental adjustment to cancer, health related QoL, costs
- TimepointsT0 - baseline
T1 - post-intervention
T2 - 3 months follow-up
T3 - 6 months follow-up
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anja van der Hout
- CONTACT for SCIENTIFIC QUERIES Anja van der Hout
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Alpe d’HuZes Foundation
- Publications-
- Brief summaryBackground: Cancer survivors have to deal with a wide range of physical symptoms and psychological, social, and existential concerns related to cancer and its treatment. Supportive care in cancer addresses survivors’ symptoms and concerns. Oncokompas2.0 was developed to meet cancer survivors’ individual supportive care needs. A RCT will be conducted to determine the reach, efficacy and cost-utility of Oncokompas2.0 as a self-management application in cancer survivors.
Methods/design: Adult patients diagnosed with breast, colorectal, head and neck cancer or lymphoma, who have been 3 months – 5 year after curative treatment will be included. In total 544 cancer survivors are randomly assigned to the intervention group or a waiting list control group. Primary outcome measures are patient empowerment and self-efficacy. Secondary outcomes include need for supportive care, mental adjustment to cancer, QOL, and costs. Questionnaires will be administered at baseline, 1 week post-intervention, and at 3, 6, and 12 months follow-up. Participants in the control group get access to Oncokompas2.0 after 6 months.
Discussion: This study evaluates the reach, efficacy, cost-utility of Oncokompas2.0 among cancer survivors. Evaluation of Oncokompas2.0 will take place using the RE-AIM framework.
- Main changes (audit trail)4-jun-2016:

Timepoints NEW:
- T4 – 12 months follow-up
- RECORD8-mrt-2016 - 4-jun-2016


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