Clinical trial NCT03981809: Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan
Official title: Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Survivors
Cancer Pain
Keywords: Pain
Cancer
Chronic pain
Persistent pain
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2019-06-11
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: An adequate selection of physiotherapy treatment for persistent pain after the treatment of cancer, depends highly on the mechanism of the pain.

Pain can arise from a damaged nerve or tissue (skin, lymphatic system...). But when pain becomes chronic, alterations to the central nervous system can occur, as regulations of the facilitating and inhibiting mechanisms. These alterations may cause central sensitization pain. The body is now sensitized and cannot distinct harmful from harmless stimuli.

Each type of pain requires a specific treatment, therefore identification of the pain mechanism is crucial. Up till now, expensive and complex tests were performed in a hospital setting to determine if a patient suffers from neuropathic, nociceptive or central sensitization pain. This study aims for developping an assessment tool that does not require expensive devices but can be easily performed by any physiotherapist, within the timeframe of a standard consultation.

Eligibility criteria: 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

Primary outcomes:
measure: Douleur Neuropathic 4 questions (DN4) questionnaire
timeFrame: 2 minutes
measure: Quantitative sensory testing
timeFrame: 20 minutes
measure: Pain mapping
timeFrame: 1 minute
measure: Central Sensitization Inventory (CSI) questionnaire
timeFrame: 5 minutes
measure: Conditioned pain modulation
timeFrame: 10 minutes
measure: Temporal summation
timeFrame: 2,5 minutes
measure: Diffuse pain
timeFrame: 0,5 minute
measure: Manual palpation
timeFrame: 3 minutes
measure: Evaluation of skin
timeFrame: 20 seconds
measure: Lymphedema
timeFrame: 4 minutes
measure: Joint pain
timeFrame: 30 seconds
measure: Active mobility
timeFrame: 2,5 minutes
measure: Passive mobility
timeFrame: 3,5 minutes
measure: Strength
timeFrame: 1,5 minutes
measure: Scar tissue
timeFrame: 2 minutes
measure: Axillary web syndrome
timeFrame: 2 minutes
Secondary outcomes:
measure: Pain catastrophizing scale
timeFrame: 6 minutes
measure: Depression, anxiety and stress
timeFrame: 7 minutes
measure: Pain Self-efficacy and Expectations: questionnaire
timeFrame: 5 minutes
measure: Pain character: questionnaire
timeFrame: 4 minutes
measure: Pain disability: Pain Disability Index
timeFrame: 3 minutes
measure: Pain intensity: Visual Analogue Scale
timeFrame: 1 minute
measure: Pain questionnaire
timeFrame: 30 seconds
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: UZ Leuven
name: Nele Devoogdt, Prof.
role: STUDY_DIRECTOR
References: