Effectiveness of a Modern Educational Intervention in Breast Cancer Patients

Pain Clinical Trial

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Official title:

The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351075
• Other study ID #: s60702
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: September 5, 2021

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: September 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Pain

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)