Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
Not provided
Not provided
Not provided
Not provided
BREACE is a prospective randomized controlled trial. The aim is to investigate the effect of an exercise-based intervention among older participants with breast cancer treated with adjuvant or first-line systemic therapy.
The hypotheses: That the intervention will maintain or increase physical function levels, reduce symptoms and side effects, improve quality of life and psychological wellbeing, and prevent weight loss and muscle wasting
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (n=50) | Experimental | Patients in the intervention group will receive standard care and a 12-week exercise-based intervention. |
|
| Control group (n=50) | No Intervention | Patient in the control group will receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast cancer exercise intervention | Other | The exercise-based intervention is comprised of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 30-second chair stand test | To measure change over time in the lower extremity strength, the number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest, is registered. | baseline, 6 weeks, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The 6-meter Gait Speed Test | To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist. | baseline, 6 weeks, 12 weeks and 24 weeks |
| The 10-meter Gait Speed Test |
Not provided
Inclusion Criteria:
Participants must:
Exclusion Criteria:
Participants with:
In patients with documented bone metastases:
- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Herlev | Copenhagen | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33033025 | Derived | Andersen HH, Mikkelsen MK, Lundager I, Lund CM, Johansen JS, Vinther A, Bogh Juhl C, Zerahn B, Ragle AM, Nielsen DL. Exercise in older women with breast cancer during systemic therapy: study protocol of a randomised controlled trial (BREACE). BMJ Open. 2020 Oct 7;10(10):e038674. doi: 10.1136/bmjopen-2020-038674. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2018 | Aug 22, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Participants will be randomized 1:1 to the intervention group and control group
Not provided
Not provided
All physical tests will be conducted by masked health care professionals.
|
To asses physical performance at normal and maximal gait speed. The assessment will be conducted by blinded physiotherapist
| baseline, 6 weeks, 12 weeks and 24 weeks |
| The 6-minute-walk-test | To measure physical capacity and endurance. The distance (measured in meters) a participant is able to walk over a total of six minutes on a hard flat surface. The assessments will be conducted by a blinded physiotherapist | baseline, 6 weeks, 12 weeks and 24 weeks |
| The Handgrip Strength Test | Physical function of the upper body will be measured using hand-held dynamometer. The assessment will be conducted by blinded physiotherapist | baseline, 6 weeks, 12 weeks and 24 weeks |
| Stair climb test | To measure lower extremity muscle power. The patient will climb a flight of stairs (20 steps) as fast as possible. The assessment will be conducted by blinded physiotherapist. | baseline, 6 weeks, 12 weeks and 24 weeks |
| Adherence to exercise sessions | Number of exercise sessions attended out of planned sessions | Up to 12 weeks |
| Physical activity level | Data of step counts will be assessed daily for participants in the intervention group and will be measured with an activity tracker. | baseline and 12 weeks |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 | Measure quality of life with the EORTC QLQ-C30 patient questionnaire. The questionnaire comprises 30 items, is designed to be cancer specific, and consists of six functional scales (physical, role, cognitive, emotional, social functioning, and global QOL) and symptom scales (fatigue, nausea/vomiting, sleep disturbance, constipation, diarrhea, appetite loss, dyspnea). | baseline, 6 weeks, 12 weeks and 24 weeks |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23 | Measure quality of life with the EORTC QLQ-BR23 patient questionnaire. The questionnaire is a breast cancer specific module to EORTC-QLQ-C30, comprises 23 items and consist of functional scales and symptom scales. Each item is scored on a scale from 1 to 4. 1 being "not at all" and 4 being "very much". | baseline, 6 weeks, 12 weeks and 24 weeks |
| M.D. Anderson Symptom Inventory (MDASI) | The MDASI patient questionnaire measures the severity of symptoms and the interference with daily living asses by the participant based on the last 24 hours. The questionnaire consist of 13 core symptom items representing symptoms that have been found to have the highest frequency and/or severity among cancer patients with various cancers and treatment types, and 6 interference items representing commonly experienced symptom interference with daily activities. | baseline, 6 weeks, 12 weeks and 24 weeks |
| Hospital Anxiety and Depression Scale (HADS) | Measure symptoms of depression and anxiety with the HADS patient questionnaire. The questionnaire comprises a total of 14 items, generates ordinal data, and is designed to measure general anxiety and depression by self-administration. Seven of the items relate to anxiety and seven relate to depression. Each item is scored on a scale from 0 to 3 and this mean a participant can score between 0 and 21 for either anxiety and depression. Scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. | baseline, 6 weeks, 12 weeks and 16 weeks |
| Common Toxicity Criteria for Adverse Events version 4 | Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4. Data will be collected from medical records. | up to 6 months |
| Body weight | Weight will be assessed using standard procedures (no shoes, light clothing) and will be reported in kilograms | baseline, 6 weeks, 12 weeks and 24 weeks |
| Body mass index | Reported in kg/m^2 | baseline, 6 weeks, 12 weeks and 24 weeks |
| whole-body lean body mass (LBM) | Measured with bioimpedance and DXA scans | baseline and 12 weeks |
| whole-body fat mass | Measured with bioimpedance and DXA scans | baseline and 12 weeks |
| whole-body mineral density | Measured with bioimpedance and DXA scans | baseline and 12 weeks |
| Inflammation | Inflammatory biomarkers: c-reactive protein, interleukin 6, YKL-40, GDF11 and GDF15. | Data will be recorded from the medical records |
| Number of hospitals admissions | Data will be collected from medical records | up to 6 months |
| Causes of hospitalizations | Data will be collected from medical records | up to 6 months |
| Lengths of hospitalizations | Data will be collected from medical records | up to 6 months |
| Survival | Incidences of deaths (cancer-related and other cause) will be registered. The purpose is to investigate whether the intervention may affect survival time/mortality. Data will be collected from medical records. | up to 6 months |
| Adverse events | Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events. | up to 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |