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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Breast Neoplasm; Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03351075

s60702

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups

Intervention group

Experimental group

Description:

Standard physical therapy program + Modern educational program

Treatment:

Other: Standard physical therapy program

Other: Modern educational program

Control group

Active Comparator group

Description:

Standard physical therapy program + Traditional biomedical educational program

Treatment:

Other: Standard physical therapy program

Other: Traditional biomedical educational program