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: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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
• 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	Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up)
Self-reported pain-intensity	Measured with Visual Analogue Scale	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Self-reported pain severity	Measured with the Brief Pain Inventory	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Prevalence of neuropathic pain	Measured with the Douleur Neuropathique en 4 questions (DN4)	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	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)	Measured with Von Frey monofilaments	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)	Measured with computerized thermotests	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)	Measured with Von Frey monofilaments	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)	Measured with algometer	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Widespread pain	Measured with Quantitative Sensory Tests	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	Measured with repetitive pinprick stimuli (using Von Frey Monofilament)	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	Measured with TSA-II NeuroSensory Analyzer from Medoc	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	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 and upper limb performance	Measured using accelerometers	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: pain catastrophizing	Measured with the Pain Catastrophizing scale	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, anxiety and stress	Measured with Depression Anxiety Stress scales 21	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 McGill Quality of Life questionnaire	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Socio-economic outcomes: patients perceived ability to work	Measured with the Return-to-work self-efficacy questionnaire	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	Measured with the Return-to-work questionnaire	Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)
Socio-economic outcomes: health-related costs	Self-reported questionnaire and data including health-care expenditure from publicly funded healthcare organizations and medical files	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.

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): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; 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