Effectiveness of a Modern Educational Intervention in Breast Cancer Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2021-09-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasm Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention group

Standard physical therapy program + Modern educational program

Group Type EXPERIMENTAL

Standard physical therapy program

Intervention Type 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

Modern educational program

Intervention Type 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

Control group

Standard physical therapy program + Traditional biomedical educational program

Group Type ACTIVE_COMPARATOR

Standard physical therapy program

Intervention Type 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

Traditional biomedical educational program

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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