Cancer SurvivorsPainsCanNCT03981809
Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors: PainsCan
An observational study of Cancer Survivors and Cancer Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors, Cancer Pain
- What is being tested?
- Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jun 2019to 30 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Active metastasis
- Palliative status
- Other type of cancer than mentioned in inclusion criteria
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain
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.
Read the 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.
- Conditions
- Cancer Survivors, Cancer Pain
- Being tested
- Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent pain
- Keywords
- Pain, Cancer, Chronic pain, Persistent pain
- Medical subject headings
- Cancer Pain, Pain, Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent painDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Douleur Neuropathic 4 questions (DN4) questionnaire
Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)
Measured: 2 minutes
Quantitative sensory testing
Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)
Measured: 20 minutes
Pain mapping
Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)
Measured: 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)
Measured: 5 minutes
Conditioned pain modulation
Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 minutes
Evaluation of skin
Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)
Measured: 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)
Measured: 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)
Measured: 30 seconds
Active mobility
Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2 minutes
Secondary outcomes (7)
Pain catastrophizing scale
Pain catastrophizing scale
Measured: 6 minutes
Depression, anxiety and stress
Depression Anxiety and Stress Scale (DASS-21)
Measured: 7 minutes
Pain Self-efficacy and Expectations: questionnaire
Pain self-efficacy and expectations questionnaire
Measured: 5 minutes
Pain character: questionnaire
McGill Pain questionnaire
Measured: 4 minutes
Pain disability: Pain Disability Index
Pain Disability Index
Measured: 3 minutes
Pain intensity: Visual Analogue Scale
Visual Analogue Scale at the moment, worst and least pain during the past week
Measured: 1 minute
Pain questionnaire
Brief Pain Inventory
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start13 Jun 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, An De Groef, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Nele Devoogdt, Prof., Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981809
- Sponsor's protocol ID
- S62584
- Acronym
- PainsCan
- Status last verified
- Aug 2023
- First submitted
- 20 May 2019
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Screening Tool to Identify the Dominant Pain Mechanism in Cancer Survivors With Persistent Pain
- ClinicalTrials.gov ID
- NCT03981809
- Acronym / sponsor ID
- PainsCan / S62584
- Conditions
- Cancer Survivors, Cancer Pain
- Keywords
- Pain, Cancer, Chronic pain, Persistent pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Active metastasis
- Palliative status
- Other type of cancer than mentioned in inclusion criteria
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test ("PainsCan") for the identification of the dominant pain mechanisms in cancer survivers with persistent painEasy-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. | Diagnostic test | – |
Primary outcome
Douleur Neuropathic 4 questions (DN4) questionnaire
Time frame: 2 minutes
Neuropathic pain: pain that arises from a damaged nerve is assessed with a questionnaire (1)
Quantitative sensory testing
Time frame: 20 minutes
Neuropathic pain: pain that arises from a damaged nerve is assessed by measuring thermal thresholds (2)
Pain mapping
Time frame: 1 minute
Neuropathic pain: pain that arises from a damaged nerve is assessed by painting affected areas on a body chart (3)
Central Sensitization Inventory (CSI) questionnaire
Time frame: 5 minutes
Central sensitization pain: pain caused by changes in the central nervous system is assessed with a questionnaire (1)
Conditioned pain modulation
Time frame: 10 minutes
Central sensitization pain: pain caused by changes in the central nervous system is assessed with a thermal test (2)
Temporal summation
Time frame: 2,5 minutes
Central sensitization pain: pain caused by changes in the central nervous system is assessed with a series of touch stimuli (3)
Diffuse pain
Time frame: 0,5 minute
Central sensitization pain: pain caused by changes in the central nervous system is assessed by painting affected areas on a body chart (4)
Manual palpation
Time frame: 3 minutes
Central sensitization pain: pain caused by changes in the central nervous system is assessed by applying pressure with manual palpation (5)
Evaluation of skin
Time frame: 20 seconds
Nociceptive pain: pain that arises from a damaged tissue is assessed by visual evaluation of the skin condition (1)
Lymphedema
Time frame: 4 minutes
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)
Joint pain
Time frame: 30 seconds
Nociceptive pain: pain that arises from a damaged tissue is assessed by examining if several joints are sore, especially in the morning (3)
Active mobility
Time frame: 2,5 minutes
Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the patient can perform (4)
Passive mobility
Time frame: 3,5 minutes
Nociceptive pain: pain that arises from a damaged tissue is assessed by examining the movements the clinician can perform on the patient (5)
Strength
Time frame: 1,5 minutes
Nociceptive pain: pain that arises from a damaged tissue is assessed by the strength the patient can perform in a specific movement (6)
Scar tissue
Time frame: 2 minutes
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)
Axillary web syndrome
Time frame: 2 minutes
Nociceptive pain: pain that arises from a damaged tissue is assessed by visually examining the presence of lymph cords in the axilla (8)
7 secondary outcomes
Pain catastrophizing scale
Time frame: 6 minutes
Depression, anxiety and stress
Time frame: 7 minutes
Pain Self-efficacy and Expectations: questionnaire
Time frame: 5 minutes
Pain character: questionnaire
Time frame: 4 minutes
Pain disability: Pain Disability Index
Time frame: 3 minutes
Pain intensity: Visual Analogue Scale
Time frame: 1 minute
Pain questionnaire
Time frame: 30 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nele Devoogdt, Prof. study director
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors and Cancer Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Douleur Neuropathic 4 questions (DN4) questionnaire (time frame: 2 minutes). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.