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ID
Source
Brief title
Health condition
Cancer, cancer survivors
Kanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient Activation Measure (PAM)
Secondary outcome
Self efficacy, patient empowerment, need for supportive care, mental adjustment to cancer, health related QoL, costs
Background summary
Background: 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.
Study objective
The use of Oncokompas2.0 will be superior to care as usual regarding self-efficacy, patient empowerment and costs.
Study design
T4 – 12 months follow-up
Intervention
Access to Oncokompas 2.0.
Anja van der Hout
Amsterdam 1081 BT
The Netherlands
+31(0)20-5987451
a.vander.hout@vu.nl
Anja van der Hout
Amsterdam 1081 BT
The Netherlands
+31(0)20-5987451
a.vander.hout@vu.nl
Inclusion criteria
Patients 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 criteria
Severe cognitive impairment, insufficient mastery of Dutch language, or insufficient basic internet skills.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4910 |
| NTR-old | NTR5774 |
| Other | METc VUmc : 2015.523 |