CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 184 enrolled
Drug / intervention
Standard physical therapy program +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03351075
NCT03351075N/ACompleted

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

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Nov 22, 2017·Updated Nov 21, 2024

In Brief

A clinical study evaluating Standard physical therapy program, Modern educational program, and 1 other intervention for Breast Neoplasm and Pain. Completed, enrolled 184 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartNov 27, 2017
Primary CompletionMar 5, 2021
Study CompletionSep 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.6 years ago

Interventions

Standard physical therapy programother

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 programother

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 programother

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