N/A
N=184
Effectiveness of a Modern Educational Intervention in Breast Cancer Patients
Breast Neoplasm · Pain
Bottom Line
View on ClinicalTrials.gov: NCT03351075 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Self-reported Change in Pain-related Disability — 4.22; 5.53 score on a scale — p=0.5163
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard physical therapy program (Other); Modern educational program (Other); Traditional biomedical educational program (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Change in Pain-related Disability |
4.22; 5.53 | 0.5163 |
| SECONDARY Self-reported Pain-related Disability |
3.70; 4.67; 3.13; 4.19 | 0.5655 |
| SECONDARY Self-reported Pain-intensity |
7.26; 9.49; 6.31; 10.61; 3.91; 8.71 | 0.5630 |
| SECONDARY Self-reported Central Sensitization Symptoms |
3.61; 3.43; 2.14; 2.39; 3.15; 3.43 | 0.7494 |
| SECONDARY Altered Somatosensory Functions (Touch) |
2.37; 1.76; 1.68; 1.95; 2.35; 1.87 | 0.3463 |
| SECONDARY Altered Somatosensory Functions (Temperature-warmth) |
3.54; 3.32; 2.67; 2.38; 2.74; 2.72 | 0.7708 |
| SECONDARY Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10) |
0.95; 0.21; 0.24; 0.15; 0.48; 0.17 | 0.0284 sig |
| SECONDARY Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10) |
0.30; -0.01; 0.13; -0.04; -0.13; -0.36 | 0.1948 |
| SECONDARY Self-reported Upper Limb Function |
10.05; 7.81; 8.51; 10.15; 6.56; 9.72 | 0.2915 |
| SECONDARY General Physical Activity Level |
50; 342; 1100; 261 | 0.5332 |
| SECONDARY Self-reported Emotional Functioning: Pain Catastrophizing |
0.896; 1.077; 0.894; 1.065; 0.762; 0.898 | 0.3590 |
| SECONDARY Self-reported Emotional Functioning: Depression |
0.802; 0.930; 0.625; 0.774; 0.718; 0.749 | 0.5018 |
| SECONDARY Self-reported Health-related Quality of Life |
0.19; 0.51; 0.90; 0.71; 1.07; 0.61 | 0.1745 |
| SECONDARY Socio-economic Outcomes: Return to Work Rate |
41; 30; 47; 41 | 0.074 |
| SECONDARY Altered Somatosensory Functions (Temperature-cold) |
-4.77; -5.00; -3.36; -4.16; -3.90; -4.35 | 0.8497 |
| SECONDARY Altered Somatosensory Functions (Nociception: Pinprick Sensation) |
19.77; 14.99; -22.24; 35.02; -17.91; 2.19 | 0.8584 |
| SECONDARY Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity) |
1.05; 0.94; 0.84; 0.75; 0.81; 0.78 | 0.1278 |
| SECONDARY Self-reported Emotional Functioning: Anxiety |
1.045; 0.987; 0.783; 0.839; 0.829; 0.821 | 0.7902 |
| SECONDARY Self-reported Emotional Functioning: Stress |
0.812; 0.760; 0.782; 0.721; 0.857; 0.868 | 0.7619 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03351075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.