Activity Program During Aromatase Inhibitor Therapy
- Conditions
- Early Breast Cancer
- Interventions
- Behavioral: Activity programBehavioral: Control
- Registration Number
- NCT03786198
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 375
- Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures.
- Histologically confirmed hormone-receptor-positive newly diagnosed breast cancer, AJCC (American Joint Committee on Cancer) stage I-III
- Patient had tumor removal by breast conserving surgery or mastectomy, followed by chemotherapy (if indicated) and/or radiotherapy (if indicated)
- Patient is starting adjuvant first-line endocrine treatment with an AI alone (in postmenopausal women) or combined endocrine treatment with an AI and ovarian suppression with an LHRH-agonist (in premenopausal women)
- Patient completed the PRO Form Eligibility before registration
- Patient is fluent in German, Italian, or French
- Patient is willing to wear a wrist worn activity tracker for 24 weeks
- Female patient, age ≥ 18 years
- WHO performance status 0-2
- Pre-existing severe medical conditions such as heart or lung problems or musculoskeletal conditions precluding participation in the physical activity program of moderate walking a total of 150 minutes per week as determined by the local investigator
- Mild, moderate, or severe pain (other than post-operative pain) in the last 24 hours due to muscle/joint pain on the BPI-SF single item "worst pain" ("worst pain" ≥3) within 7 days prior to registration
- Inoperable, locally advanced and/or metastatic breast cancer
- Active rheumatoid arthritis
- Neoadjuvant endocrine treatment with an AI
- NSAIDs, acetaminophen or opioids on a regular basis (> 1 time per week)
- Concurrent participation in other clinical trials or observational studies
- Any other serious psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the intervention and follow-up or affect patient compliance with trial procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description a) Home-based walking intervention Activity program Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy b) Physical activity according to standard recommendations Control 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
- Primary Outcome Measures
Name Time Method Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score Up to 24 weeks after randomization 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.
- Secondary Outcome Measures
Name Time Method Fatigue Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
QoL: Emotional scale (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
QoL: Cognitive scale (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
QoL: Social functioning scale (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
QoL: Physical scale (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
QoL: Rose scale (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Hot flashes Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Nausea/Vomiting Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Pain (EORTC QLQ-C30) Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Global health status Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Dyspnoea Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
AI treatment adherence (diary) Baseline, 3, 9, 12, 15, 18, 21, 24 weeks. Adherence will be assessed by patient self-report (diary).
Insomnia Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Appetite loss Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Constipation Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Diarrhoea Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Financial difficulties Baseline, 12 and 24 weeks and 1 and 2 years after randomization 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.
Intensity of muscle or joint pain/stiffness and its impact on everyday functioning Baseline, 3, 9, 12, 15, 18, 21, 24 weeks and 1, 2 years after randomization 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.
Walking activity Baseline, 3, 9, 12, 15, 18, 21, 24 weeks after randomization During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.
AI treatment adherence (questionnaire) Baseline, 12, 24 weeks and 1, 2 years after randomization Adherence will be assessed by patient self-report (questionnaire completed at visits).
Trial Locations
- Locations (32)
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Hirslanden Brustzentrum Bern Biel
🇨🇭Bern, Switzerland
Tumorzentrum ZeTuP Chur
🇨🇭Chur, Switzerland
Brustzentrum Thurgau
🇨🇭Frauenfeld, Switzerland
Onkologie Zentrum Spital Männedorf
🇨🇭Manno, Switzerland
Tumorzentrum ZeTuP Rapperswil-Jona
🇨🇭Rapperswil-Jona, Switzerland
Brustzentrum Ostschweiz
🇨🇭Saint Gallen, Switzerland
Kantonsspital Winterthur, Brustzentrum
🇨🇭Winterthur, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland
Brustzentrum Basel - Praxis für ambulante Tumortherapie
🇨🇭Basel, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Kantonsspital Luzern
🇨🇭Luzerne, Switzerland
Clinique De Genolier
🇨🇭Genolier, Switzerland
Oncologia Varini&Calderoni&Christinat
🇨🇭Lugano, Switzerland
Brustzentrum Zürich
🇨🇭Zürich, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
🇨🇭Mendrisio, Switzerland
Hirslanden Klinik St. Anna
🇨🇭Luzern, Switzerland
Hôpital Neuchâtelois
🇨🇭Neuenhof, Switzerland
Hôpital de Sion
🇨🇭Sion, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Tumorzentrum ZeTUP
🇨🇭St. Gallen, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Regionalspital Thun
🇨🇭Thun, Switzerland
Onkologie Bellevue
🇨🇭Zurich, Switzerland
Universitäts Spital Zürich
🇨🇭Zürich, Switzerland
Kantonsspital Graubünden
🇨🇭Chur, Switzerland
FOLM - Fondazione Oncologia Lago Maggiore
🇨🇭Locarno, Switzerland
CABA - Zentrum für Onkologie, Psychologie und Bewegung
🇨🇭Basel, Switzerland
Universitätsspital Basel
🇨🇭Basel, Switzerland
Clinique des Grangettes, Centre du sein
🇨🇭Chêne-Bougeries, Switzerland
Centre du sein Fribourg / Brustzentrum Freiburg
🇨🇭Fribourg, Switzerland
Rundum Onkologie am Bahnhofpark
🇨🇭Sargans, Switzerland