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
Not provided
Not provided
Not provided
Not provided
Not provided
The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant aromatase inhibitor (AI) therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.
After tumor removal, patients with hormone receptor positive breast cancer tumors often receive adjuvant endocrine treatment, with the use of an aromatase inhibitor (AI) being standard of care in the population of postmenopausal women. Common side effects of AI therapy are joint pain, muscle pain, stiffness, fatigue, hot flashes, and weight gain. Arthralgia and/or myalgia can result in lower physical activity and can negatively influence quality of life (QoL). In addition, muscle or joint pain/stiffness are among the main reasons for non-compliance and discontinuation of AI therapy. Because AI therapy is usually administered for 5 and sometimes even 10 years, this is a major clinical challenge.
For breast cancer patients undergoing AI therapy, physical activity can provide potential benefit by reducing muscle/joint pain and fatigue and can thus improve QoL. The preventive effect of physical activity on AI side effects, however, remains elusive. In addition, activity programs to reduce AI side effects have so far mostly been rather complex. The primary aim of the trial is to investigate if a simple outdoor walking intervention, which is practicable under real-life conditions, beginning at the start of adjuvant AI therapy, can prevent the occurrence of muscle or joint pain/stiffness in breast cancer patients.
Furthermore, this trial will assess the effect of physical activity on symptom burden in general and quality of life in patients receiving adjuvant AI therapy. During the follow-up phase, the trial will assess whether this intervention leads to a sustained change in lifestyle regarding activity, less pain, and better treatment adherence in the intervention group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a) Home-based walking intervention | Experimental | Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy |
|
| b) Physical activity according to standard recommendations | Active Comparator | Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity program | Behavioral | Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score | Muscle or joint pain/stiffness will be assessed at baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization by the BPI-SF questionnaire. The BPI-SF is a 14-item self-administered questionnaire which is routinely used in clinical trials to assess pain severity and pain interference with daily activities in patients with cancer. Pain severity is assessed by four items including pain at its "worst", "least", "average" in the last 24 hours and "now" (current pain), each item being rated on a 0-10 scale. | Up to 24 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Fatigue will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| QoL: Physical scale (EORTC QLQ-C30) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Friedemann Honecker, MD | Tumor- und Brustzentrum ZeTuP St.Gallen | Study Chair |
| Nicolette Hoefnagels, MSc | Tumor- und Brustzentrum ZeTuP St.Gallen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | 5001 | Switzerland | |||
| Kantonsspital Baden |
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Behavioral | Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy |
|
Physical scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. |
| Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| QoL: Rose scale (EORTC QLQ-C30) | Role scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| QoL: Emotional scale (EORTC QLQ-C30) | Emotional scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| QoL: Cognitive scale (EORTC QLQ-C30) | Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| QoL: Social functioning scale (EORTC QLQ-C30) | Cognitive scale will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Nausea/Vomiting | Nausea/vomiting will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Pain (EORTC QLQ-C30) | Pain will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Global health status | Global health status will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Dyspnoea | Dyspnoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Insomnia | Insomnia will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Appetite loss | Appetite loss will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Constipation | Constipation will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Diarrhoea | Diarrhoea will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Financial difficulties | Financial difficulties will be assessed at baseline, during intervention phase and during follow-up phase using the corresponding symptom scale of the EORTC QLQ-C30 version 3.0. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Hot flashes | Hot flashes will be assessed at baseline, during intervention phase and during follow-up phase via the item 37 of the EORTC QLQ BR-23. | Baseline, 12 and 24 weeks and 1 and 2 years after randomization |
| Intensity of muscle or joint pain/stiffness and its impact on everyday functioning | Severity of muscle or joint pain/stiffness will be measured by the four BPI pain severity items. Pain interference will be calculated as the mean of the seven interference items. | Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization |
| Walking activity | During trial intervention phase, daily steps will be measured by a wrist worn activity tracker. | Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization |
| AI treatment adherence (diary) | Adherence will be assessed by patient self-report (diary). | Baseline, 3, 9, 12, 15, 18, 21, 24 weeks. |
| AI treatment adherence (questionnaire) | Adherence will be assessed by patient self-report (questionnaire completed at visits). | Baseline, 12, 24 weeks and 1, 2 years after randomization |
| Baden |
| 5404 |
| Switzerland |
| CABA - Zentrum für Onkologie, Psychologie und Bewegung | Basel | 4051 | Switzerland |
| Brustzentrum Basel - Praxis für ambulante Tumortherapie | Basel | 4052 | Switzerland |
| Universitätsspital Basel | Basel | CH-4031 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Hirslanden Brustzentrum Bern Biel | Bern | 3013 | Switzerland |
| Clinique des Grangettes, Centre du sein | Chêne-Bougeries | 1224 | Switzerland |
| Kantonsspital Graubünden | Chur | 7000 | Switzerland |
| Tumorzentrum ZeTuP Chur | Chur | 7000 | Switzerland |
| Brustzentrum Thurgau | Frauenfeld | 8501 | Switzerland |
| Centre du sein Fribourg / Brustzentrum Freiburg | Fribourg | 1700 | Switzerland |
| Clinique De Genolier | Genolier | 1272 | Switzerland |
| FOLM - Fondazione Oncologia Lago Maggiore | Locarno | 6600 | Switzerland |
| Hirslanden Klinik St. Anna | Lucerne | 6006 | Switzerland |
| Oncologia Varini&Calderoni&Christinat | Lugano | 6900 | Switzerland |
| Kantonsspital Luzern | Luzerne | CH-6000 | Switzerland |
| Onkologie Zentrum Spital Männedorf | Manno | 8708 | Switzerland |
| Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli | Mendrisio | 6850 | Switzerland |
| Hôpital Neuchâtelois | Neuenhof | 2000 | Switzerland |
| Kantonsspital Olten | Olten | 4600 | Switzerland |
| Tumorzentrum ZeTuP Rapperswil-Jona | Rapperswil-Jona | 8640 | Switzerland |
| Tumorzentrum ZeTUP | Sankt Gallen | 9006 | Switzerland |
| Brustzentrum Ostschweiz | Sankt Gallen | 9016 | Switzerland |
| Kantonsspital St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Rundum Onkologie am Bahnhofpark | Sargans | 7320 | Switzerland |
| Hôpital de Sion | Sion | Switzerland |
| Regionalspital Thun | Thun | 3600 | Switzerland |
| Kantonsspital Winterthur, Brustzentrum | Winterthur | 8401 | Switzerland |
| Onkologie Bellevue | Zurich | 8001 | Switzerland |
| Brustzentrum Zürich | Zurich | 8008 | Switzerland |
| Universitäts Spital Zürich | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D003133 | Commission on Professional and Hospital Activities |
| ID | Term |
|---|---|
| D008485 | Medical Audit |
| D054869 | Clinical Audit |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided