Effectiveness of a Modern Educational Intervention in Breast Cancer Patients (EduCan)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breast Neoplasm
• Intervention / Treatment: Other: Standard physical therapy program; Other: Modern educational program; Other: Traditional biomedical educational program

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Active metastasis
• Cannot participate during the entire study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Standard physical therapy program + Modern educational program	Other: Standard physical therapy program; 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; Other: Modern educational program; 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
Active Comparator: Control group; Standard physical therapy program + Traditional biomedical educational program	Other: Standard physical therapy program; 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; Other: Traditional biomedical educational program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change between baseline and one year follow-up assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	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	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.	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.	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.	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.	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.	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Lore Dams, Dra, University of Leuven; Principal Investigator: Elien Van der Gucht, Dra, University of Leuven

Publications and helpful links

General 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.
• Dams 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.
• Dams 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.
• De 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): September 5, 2021

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: s60702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No