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Activity Program During Aromatase Inhibitor Therapy

Primary Purpose

Early Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Activity program

Control

About this trial

This is an interventional supportive care trial for Early Breast Cancer focused on measuring early breast cancer, aromatase inhibitor therapy, activity program, physical activity, activity tracker, pedometer, stepcounter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Kantonsspital Aarau
Kantonsspital Baden
CABA - Zentrum für Onkologie, Psychologie und Bewegung
Brustzentrum Basel - Praxis für ambulante Tumortherapie
Universitätsspital Basel
Inselspital Bern
Hirslanden Brustzentrum Bern Biel
Kantonsspital Graubünden
Tumorzentrum ZeTuP Chur
Clinique des Grangettes, Centre du sein
Brustzentrum Thurgau
Centre du sein Fribourg / Brustzentrum Freiburg
Clinique De Genolier
FOLM - Fondazione Oncologia Lago Maggiore
Oncologia Varini&Calderoni&Christinat
Kantonsspital Luzern
Hirslanden Klinik St. Anna
Onkologie Zentrum Spital Männedorf
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Hôpital Neuchâtelois
Kantonsspital Olten
Tumorzentrum ZeTuP Rapperswil-Jona
Brustzentrum Ostschweiz
Rundum Onkologie am Bahnhofpark
Hôpital de Sion
Tumorzentrum ZeTUP
Kantonsspital St. Gallen
Regionalspital Thun
Kantonsspital Winterthur, Brustzentrum
Onkologie Bellevue
Brustzentrum Zürich
Universitäts Spital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

a) Home-based walking intervention

b) Physical activity according to standard recommendations

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

QoL: Physical scale (EORTC QLQ-C30)

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)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Walking activity

During trial intervention phase, daily steps will be measured by a wrist worn activity tracker.

AI treatment adherence (diary)

Adherence will be assessed by patient self-report (diary).

AI treatment adherence (questionnaire)

Adherence will be assessed by patient self-report (questionnaire completed at visits).

Full Information

NCT ID

NCT03786198

First Posted

December 14, 2018

Last Updated

June 26, 2023

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT03786198

Brief Title

Activity Program During Aromatase Inhibitor Therapy

Official Title

A 24 Weeks Activity Program in Patients With Early Breast Cancer Receiving Aromatase Inhibitor Therapy. A Multicenter Randomized Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

March 28, 2019 (Actual)

Primary Completion Date

September 27, 2021 (Actual)

Study Completion Date

June 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Home-based walking intervention for 24 weeks + standard adjuvant AI therapy Physical activity according to standard recommendations for 24 weeks + standard adjuvant AI therapy

Masking

None (Open Label)

Allocation

Randomized

Enrollment

375 (Actual)

8. Arms, Groups, and Interventions

Arm Title

a) Home-based walking intervention

Arm Type

Experimental

Arm Description

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

Arm Title

b) Physical activity according to standard recommendations

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Activity program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

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 Measure Information:

Title

Incidence of muscle or joint pain/stiffness as measured by BPI-SF single-item worst pain score

Description

Time Frame

Up to 24 weeks after randomization

Secondary Outcome Measure Information:

Title

Fatigue

Description

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.

Time Frame