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Effects of a multifaceted *teleguided* pain care programs in patients with cancer

Effects of a multifaceted *teleguided* pain care programs in patients with cancer - Self management support in cancer pain * effect evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38991
Enrollment
174
Registered
2013-11-18
Start date
2014-02-25
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cancer pain oncologic pain

Interventions

The system consists of an iPad application for the patient and a web-application for the health professional (nurse and treating physician). The applications are embedded in a health care organisati

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of cancer - Patients who are under (palliative) anti-tumour treatment in a day clinic or outpatient clinic, or patients who have no treatment options available anymore - Cancer (treatment related) pain > 2 weeks - Pain is defined as a patient reported pain score * 4 on a numerical rating scale (NRS, scale 0-10) - Living at home

Exclusion criteria

Exclusion criteria: - Expected life expectancy

Design outcomes

Primary

MeasureTime frame
The primary outcomes of the effect evaluation are pain intensity and quality of life. - Pain intensity is measured with the Brief Pain Inventory (BPI), an instrument frequently used to monitor pain in the clinical and research setting (Cleeland 1994; Jensen, 2003). - Quality of life is measured with the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30 version 3). This instrument is cancer specific, multi-dimensional and appropriate for self-administration. The EORTC-QLQ-C30 has shown acceptable levels of reliability and validity (Aaronson et al., 1993).

Secondary

MeasureTime frame
Secondary outcomes measures for the effect evaluation include self-efficacy, knowledge, anxiety and depression, and medication use. - Self-efficacy is measured with the Chronic Pain Self-efficacy Scale (CPSS-DLV). The Dutch language version of the CPSS has two subscales (pain and symptom management and physical functioning), each consisting of 10 items. Patients score the items on a 10-100 scale, 10 representing very unsecure and 100 very secure. Reliability and validity have been demonstrated for different pain conditions (Köke, unpublished). - Ferrell*s Patient Pain Knowledge Questionnaire (PKQ-DLV) will be used to measure knowledge. The questionnaire includes eight items that will be transformed to a 0-100 scale (0 is the lowest knowledge score; 100 is the highest knowledge score). The PKQ-DLV has an acceptable reliability and validity (De Wit, 1999). - Anxiety and depression will be measured with the Hospital Anxiety and Depression Scale (HADS). The HADS showed good performance to assess symptom severity, anxiety disorders (alpha 0.67-0.90) and depression (0.67-0.90) in somatic, psychiatric and primary care patients, with a sensitivity and specificity of approximately 0.80 (Bjelland et al., 2002; Spinhoven et al., 1997) - Information about medication use will be derived from the regular patient passport of the pharmacist. Other demographic and medical data will be collected at the first measurement and retrieved from the medical record. The outcome measure for the economic evaluation is costs per QALY. - Cost utility will be measured with the EuroQol (EQ-5D-5L). This is a self-administered questionnaire which consists of five dimensions of health-related quality of life (mobility, self-care, daily activity, pain/discomfort and anxiety/depression). These dimensions can be added to comprise an overall health state that will be translated to a utility. Utility rates, derived from the Doran algorithm, will be used to compute QALY*s (Euro

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)