Breast NeoplasmEduCanNCT03351075
Effectiveness of a Modern Educational Intervention in Breast Cancer Patients
A study testing Standard physical therapy program, Modern educational program and Traditional biomedical educational program in people with Breast Neoplasm and Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm, Pain
- What is being tested?
- Standard physical therapy program, Modern educational program and Traditional biomedical educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Nov 2017to 5 Sep 2021
- Phase
- Interventional
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary breast cancer
- Unilateral surgery including, either:
- Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery
Who cannot join
- Active metastasis
- Cannot participate during the entire study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial
In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.
- Conditions
- Breast Neoplasm, Pain
- Being tested
- Standard physical therapy program, Modern educational program, Traditional biomedical educational program
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physical therapy programOther
Mobilisations, stretching, scar tissue treatment and exercises
- Start immediately after surgery, sessions are individual and take 30 minutes
- Intensive phase (4 months): 1-2x/week
- Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational programOther
This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
- Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
- 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
Traditional biomedical educational programOther
Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
- Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
- 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Standard physical therapy program + Modern educational program Receives: Other: Standard physical therapy program; Other: Modern educational program |
| Control group | Active comparator | Standard physical therapy program + Traditional biomedical educational program Receives: Other: Standard physical therapy program; Other: Traditional biomedical educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Change in Pain-related Disability
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
Measured: Change between baseline and one year follow-up assessment
Secondary outcomes (18)
Self-reported Pain-related Disability
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
Measured: Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up)
Self-reported Pain-intensity
Measured with Visual Analogue Scale (0-100), lower scores indicate a better outcome.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Central Sensitization Symptoms
Measured with the Central Sensitization Inventory (0-100). The Central Sensitization Inventory (CSI) includes 25 items about symptoms related to altered central somatosensory functioning, scored on a five-point Likert scale from 0 (never) to 4 (always). Scores range from 0-100 and a higher score represents greater symptomatology associated with altered central somatosensory processing.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Altered Somatosensory Functions (Touch)
Mechanical detection sensitivity (mN) measured with Von Frey monofilaments at the arm at the affected side. A series of stimulus intensities are given and the stimulus intensity (mN) that is first identified is recorded (min-max 8 mN-512 mN). A lower value indicates a higher sensitivity to mechanical sensitivity.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Altered Somatosensory Functions (Temperature-warmth)
Thermal detection sensitivity (degrees Celsius) for warmth at the arm at the affected side measured with computerized thermotests. Temperature when a change from a thermoneutral state to a distinct warm is recorded. A lower value indicates a higher sentivity to temperature.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10)
Measured with repetitive pinprick stimuli (using Von Frey Monofilament of 256 mN) at the pectoral region of the affected side. Pain rating after a single stimulation and after 30s of stimulation is recorded. The outcome of interest is the pain rating after 30s stimulation - pain rating single stimulation on a Numeric Rating Scale (0-10) with lower scores meaning less endogenous pain facilitation.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10)
Conditioned Pain Modulation Measured with TSA-II NeuroSensory Analyzer from Medoc. Parallel heat design is used with
- Test stimulus (45s): Individually determined test stimulus (temperature with a Numeric Rating Scale score of at least 4 out of 10) applied alone. Pain rating (Numeric Rating Scale 0-10) at 10s, 20s, 30s and 40s of stimulation.
- Break (120s)
- Conditioning stimulus (temperature of test stimulus + 0.5°C) (65s) + test stimulus in parallel (45s). Pain rating (Numeric Rating Scale 0-10) at 10s, 20s, 30s and 40s of stimulation. The outcome of interest is the a rithmetic mean differences between the Numeric Rating Scale score of the conditioning + test stimulus and test stimulus alone for 4 10s-long epochs (Numeric Rating Scale 0-10) Lower scores indicate better endogenous pain inhibition.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Upper Limb Function
Measured with Disability of Arm, Shoulder and Hand Questionnaire (0-100) with lower scores indicating less disability.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
General Physical Activity Level
Step count average (steps/day) measured with an accelerometer
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment)
Self-reported Emotional Functioning: Pain Catastrophizing
Measured with the Pain Catastrophizing scale (0-52), with higher scores corresponding to more pain-related catastrophizing.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Emotional Functioning: Depression
Measured with Depression Anxiety Stress scales 21(0-42) with lower scores indicating less depression.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Health-related Quality of Life
Measured with the existential well-being sub scale of the McGill Quality of Life questionnaire (0-10) with higher scores reflecting a better health-related quality of life.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Socio-economic Outcomes: Return to Work Rate
Work status at 12 and 18 months postoperatively, i.e. the proportion of women working at 12 and 18 months after surgery, respectively
Measured: Postoperatively after 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Altered Somatosensory Functions (Temperature-cold)
Thermal detection sensitivity (degrees Celsius) for cold at the arm at the affected side measured with computerized thermotests. Temperature when a change from a thermoneutral state to a distinct cold is recorded.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Altered Somatosensory Functions (Nociception: Pinprick Sensation)
Mechanical pain sensitivity (mN) measured at the arm at the affected side with Von Frey Monofilaments. A series of stimulus intensities are given and the stimulus intensity that is first identified as painful (not unbearable) is recorded (mN). Min-max 8mN-512mN.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity)
Pressure pain sensitivity (kgf) at the pectoralis region at the affected side measured with an algometer. The amount of pressure (kgs) by which the perception of pressure turns for the first time into a painful (not unbearable) sensation. Lower values indicate higher pain sensitivity.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Emotional Functioning: Anxiety
Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less anxiety.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported Emotional Functioning: Stress
Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less stress.
Measured: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start27 Nov 2017
- Primary completion5 Mar 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Lore Dams, Dra, Principal investigator, University of LeuvenElien Van der Gucht, Dra, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351075
- Sponsor's protocol ID
- s60702
- Acronym
- EduCan
- Status last verified
- May 2022
- First submitted
- 4 Oct 2017
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Groef A, Devoogdt N, Van der Gucht E, Dams L, Bernar K, Godderis L, Morlion B, Moloney N, Smeets A, Van Wilgen P, Meeus M. EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning. BMJ Open. 2019 Jan 4;9(1):e025742. doi: 10.1136/bmjopen-2018-025742.
PubMed 30612114Dams L, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, Haenen V, De Vrieze T, Fieuws S, Moloney N, Van Wilgen P, Meeus M, De Groef A. Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial). Pain. 2023 Jul 1;164(7):1489-1501. doi: 10.1097/j.pain.0000000000002838. Epub 2022 Dec 8.
PubMed 36637138Dams L, Van der Gucht E, Haenen V, Devoogdt N, Smeets A, Bernar K, Morlion B, Moloney N, Fieuws S, De Groef A, Meeus M. Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial. Anat Rec (Hoboken). 2024 Feb;307(2):248-272. doi: 10.1002/ar.25127. Epub 2023 Jan 3.
PubMed 36594663De Groef A, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, De Vrieze T, Fieuws S, Meeus M, Dams L. Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education. J Occup Rehabil. 2023 Dec;33(4):757-765. doi: 10.1007/s10926-023-10103-9. Epub 2023 May 12.
PubMed 37171771Van Dijck S, De Groef A, Mertens M, Devoogdt N, Van Overbeke M, Meeus M, Van der Gucht E, Dams L. Pain-related variables as contributing factors to physical activity after breast cancer surgery: a one-year follow-up study. J Behav Med. 2025 Dec;48(6):901-917. doi: 10.1007/s10865-025-00607-5. Epub 2025 Oct 5.
PubMed 41047438Amber G, Lore D, Elien VG, Jan S, Michel M, An G, Mira M. From breast cancer diagnosis to survivorship: Analyzing perioperative biopsychosocial phenotypes and their relationship to pain on long term. J Pain. 2025 Jan;26:104709. doi: 10.1016/j.jpain.2024.104709. Epub 2024 Oct 16.
PubMed 39419367