Effectiveness of a Modern Educational Intervention in Breast Cancer Patients

NCT03351075 | Completed Results

• 1 other identifier: s60702
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Self-reported Pain-related Disability

  Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up)

• Self-reported Pain-intensity

  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

  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)

  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)

  Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)

Study Arms (2)

Intervention group

EXPERIMENTAL

Standard physical therapy program + Modern educational program

Other: Standard physical therapy program; Other: Modern educational program

Control group

ACTIVE COMPARATOR

Standard physical therapy program + Traditional biomedical educational program

Other: Standard physical therapy program; Other: Traditional biomedical educational program

Interventions

Standard physical therapy program OTHER

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

Control group; Intervention group

Modern educational program OTHER

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

Intervention group

Traditional biomedical educational program OTHER

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

Control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active metastasis
• Cannot participate during the entire study period

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (5)

• 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.

  PMID: 30612114 BACKGROUND

• 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.

  PMID: 36637138 RESULT

• 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.

  PMID: 36594663 RESULT

• 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.

  PMID: 37171771 RESULT

• Amber 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.

  PMID: 39419367 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. An De Groef
• Organization: KU Leuven

an.degroef@kuleuven.be

+32 16 342 171

Study Officials

• Lore Dams, Dra

  University of Leuven

  PRINCIPAL INVESTIGATOR

• Elien Van der Gucht, Dra

  University of Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 22, 2017
• Study Start: November 27, 2017
• Primary Completion: March 5, 2021
• Study Completion: September 5, 2021
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2022-05

Locations

BE (1)