Activity Program During Aromatase Inhibitor Therapy

NCT03786198 | Completed DMC

• 1 other identifier: SAKK 95/17
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 32

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.

Conditions

Early Breast Cancer

Keywords

early breast cancer; aromatase inhibitor therapy; activity program; physical activity; activity tracker; pedometer; stepcounter

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• Fatigue

  Baseline, 12 and 24 weeks and 1 and 2 years after randomization

• QoL: Physical scale (EORTC QLQ-C30)

  Baseline, 12 and 24 weeks and 1 and 2 years after randomization

• QoL: Rose scale (EORTC QLQ-C30)

  Baseline, 12 and 24 weeks and 1 and 2 years after randomization

• QoL: Emotional scale (EORTC QLQ-C30)

  Baseline, 12 and 24 weeks and 1 and 2 years after randomization

• QoL: Cognitive scale (EORTC QLQ-C30)

  Baseline, 12 and 24 weeks and 1 and 2 years after randomization

Study Arms (2)

a) Home-based walking intervention

EXPERIMENTAL

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks + standard adjuvant AI therapy

Behavioral: Activity program

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

Behavioral: Control

Interventions

Activity program BEHAVIORAL

Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks

a) Home-based walking intervention

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

b) Physical activity according to standard recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (32)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

CABA - Zentrum für Onkologie, Psychologie und Bewegung

Basel, 4051, Switzerland

Location

Brustzentrum Basel - Praxis für ambulante Tumortherapie

Basel, 4052, Switzerland

Location

Universitätsspital Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Hirslanden Brustzentrum Bern Biel

Bern, 3013, Switzerland

Location

Clinique des Grangettes, Centre du sein

Chêne-Bougeries, 1224, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Tumorzentrum ZeTuP Chur

Chur, 7000, Switzerland

Location

Brustzentrum Thurgau

Frauenfeld, 8501, Switzerland

Location

Centre du sein Fribourg / Brustzentrum Freiburg

Fribourg, 1700, Switzerland

Location

Clinique De Genolier

Genolier, 1272, Switzerland

Location

FOLM - Fondazione Oncologia Lago Maggiore

Locarno, 6600, Switzerland

Location

Hirslanden Klinik St. Anna

Lucerne, 6006, Switzerland

Location

Oncologia Varini&Calderoni&Christinat

Lugano, 6900, Switzerland

Location

Kantonsspital Luzern

Luzerne, CH-6000, Switzerland

Location

Onkologie Zentrum Spital Männedorf

Manno, 8708, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Mendrisio, 6850, Switzerland

Location

Hôpital Neuchâtelois

Neuenhof, 2000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil-Jona, 8640, Switzerland

Location

Tumorzentrum ZeTUP

Sankt Gallen, 9006, Switzerland

Location

Brustzentrum Ostschweiz

Sankt Gallen, 9016, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Rundum Onkologie am Bahnhofpark

Sargans, 7320, Switzerland

Location

Hôpital de Sion

Sion, Switzerland

Location

Regionalspital Thun

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur, Brustzentrum

Winterthur, 8401, Switzerland

Location

Onkologie Bellevue

Zurich, 8001, Switzerland

Location

Brustzentrum Zürich

Zurich, 8008, Switzerland

Location

Universitäts Spital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Commission on Professional and Hospital Activities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Medical Audit; Clinical Audit; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Friedemann Honecker, MD

  Tumor- und Brustzentrum ZeTuP St.Gallen

  STUDY CHAIR

• Nicolette Hoefnagels, MSc

  Tumor- und Brustzentrum ZeTuP St.Gallen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Home-based walking intervention for 24 weeks + standard adjuvant AI therapy 2. Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 24, 2018
• Study Start: March 28, 2019
• Primary Completion: September 27, 2021
• Study Completion: June 8, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CH (32)