Cancer Pain Clinical Trial
— PainsCanOfficial title:
Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain
NCT number | NCT03981809 |
Other study ID # | S62584 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2019 |
Est. completion date | December 30, 2022 |
Verified date | August 2023 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Development and internal validation of an easy-to-use tool for clinical pain assessment. The tool has to be applicable in any clinical practice and without the need for expensive and complicated hospital tools to identify the source of persistent pain after the treatment of cancer.
Status | Completed |
Enrollment | 92 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient treated for primary cancer: breast, prostate, lung/bronchus, colon/rectum, gynecologic (uterus or ovary) - Complete remission - Curative treatment finished - Ongoing hormonal and targeted treatment permitted - Patient experiences pain (NRS minimum 3/10 during the past week) Exclusion Criteria: - Active metastasis - Palliative status - Other type of cancer than mentioned in inclusion criteria - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | Fund for Scientific Research, Flanders, Belgium |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Douleur Neuropathic 4 questions (DN4) questionnaire | Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1) | 2 minutes | |
Primary | Quantitative sensory testing | Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2) | 20 minutes | |
Primary | Pain mapping | Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3) | 1 minute | |
Primary | Central Sensitization Inventory (CSI) questionnaire | Central sensitization pain: pain caused by changes in the central nervous system is assessed with a questionnaire (1) | 5 minutes | |
Primary | Conditioned pain modulation | Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2) | 10 minutes | |
Primary | Temporal summation | Central sensitization pain: pain caused by changes in the central nervous system is assessed with a series of touch stimuli (3) | 2,5 minutes | |
Primary | Diffuse pain | Central sensitization pain: pain caused by changes in the central nervous system is assessed by painting affected areas on a body chart (4) | 0,5 minute | |
Primary | Manual palpation | Central sensitization pain: pain caused by changes in the central nervous system is assessed by applying pressure with manual palpation (5) | 3 minutes | |
Primary | Evaluation of skin | Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1) | 20 seconds | |
Primary | Lymphedema | Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the presence of lymphedema by measuring the circumference of the arm (2) | 4 minutes | |
Primary | Joint pain | Nociceptive pain: pain that arises from a damaged tissue is assessed by examining if several joints are sore, especially in the morning (3) | 30 seconds | |
Primary | Active mobility | Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4) | 2,5 minutes | |
Primary | Passive mobility | Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the clinician can perform on the patient (5) | 3,5 minutes | |
Primary | Strength | Nociceptive pain: pain that arises from a damaged tissue is assessed by the strength the patient can perform in a specific movement (6) | 1,5 minutes | |
Primary | Scar tissue | Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the elasticity of the scar tissue by manual palpation of the clinician (7) | 2 minutes | |
Primary | Axillary web syndrome | Nociceptive pain: pain that arises from a damaged tissue is assessed by visually examining the presence of lymph cords in the axilla (8) | 2 minutes | |
Secondary | Pain catastrophizing scale | Pain catastrophizing scale | 6 minutes | |
Secondary | Depression, anxiety and stress | Depression Anxiety and Stress Scale (DASS-21) | 7 minutes | |
Secondary | Pain Self-efficacy and Expectations: questionnaire | Pain self-efficacy and expectations questionnaire | 5 minutes | |
Secondary | Pain character: questionnaire | McGill Pain questionnaire | 4 minutes | |
Secondary | Pain disability: Pain Disability Index | Pain Disability Index | 3 minutes | |
Secondary | Pain intensity: Visual Analogue Scale | Visual Analogue Scale at the moment, worst and least pain during the past week | 1 minute | |
Secondary | Pain questionnaire | Brief Pain Inventory | 30 seconds |
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