SAKK 95/17 - Eine 24-wöchige Bewegungsstudie für Patientinnen mit lokal begrenztem Brustkrebs unter Aromatase-Inhibitor-Therapie

Behavioral: Activity program;Behavioral: Control

Gender: Female
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.