Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan

NCT03981809 | Completed DMC

• 1 other identifier: S62584
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivors; Cancer Pain

Keywords

Pain; Cancer; Chronic pain; Persistent pain

Outcome Measures

Primary Outcomes (16)

• Douleur Neuropathic 4 questions (DN4) questionnaire

  Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)

  2 minutes

• Quantitative sensory testing

  Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)

  20 minutes

• Pain mapping

  Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)

  1 minute

• 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

• Conditioned pain modulation

  Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)

  10 minutes

• 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

• 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

• 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

• Evaluation of skin

  Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)

  20 seconds

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Pain catastrophizing scale

  6 minutes

• Depression, anxiety and stress

  7 minutes

• Pain Self-efficacy and Expectations: questionnaire

  5 minutes

• Pain character: questionnaire

  4 minutes

• Pain disability: Pain Disability Index

  3 minutes

Interventions

Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain DIAGNOSTIC_TEST

Easy-to-use screening tool to identify the dominant pain mechanism by using quick clinical tests and compare their accuracy and validity with complicated reference tests.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients older than 18, in complete remission, who experience pain scored with a minimum of 3/10 (0 being no pain at all and 10 being the worst pain imaginable). The patients do not have metastasis and are not in a palliative status, nor are they pregnant or diagnosed with a cancer type other than breast, prostate, lung/bronchus, colon/rectum or gynecologic cancer.

You may qualify if:

• 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)

You may not qualify if:

• Active metastasis
• Palliative status
• Pregnancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Cancer Pain; Pain; Neoplasms; Chronic Pain

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nele Devoogdt, Prof.

  UZ Leuven

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator An De Groef

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 11, 2019
• Study Start: June 13, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

BE (1)