Step by Step After Cancer
SBSAC
Evaluating the Effectiveness of Supervised Practice or Distance Supervised Physical Activity (Walking) in the Overall Management of Fatigue in Breast Cancer Patients During Hormonal Therapy: Pilot Study
1 other identifier
interventional
17
1 country
1
Brief Summary
After treatment, women want to regain a 'normal' lifestyle while some factors interfere as chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical deconditioning . The following protocol will focus at this problem.It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Feb 2013
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2026
CompletedFebruary 12, 2026
February 1, 2026
13 years
May 23, 2016
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fatigue of the patient with QLQC-30
6 weeks
Secondary Outcomes (2)
Global Quality of life with QLQC-30
6 weeks
Activity level with IPAQ
6 weeks
Study Arms (2)
supervised practice
EXPERIMENTALbrisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes. Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed. Each patient of supervised walking group will meet the student each session
distance supervised physical activity
EXPERIMENTALbrisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes. Biweekly session from 60% of the heart rate pic during 20 minutes will be proposed. Each patient of home-based walking group will be called by phone every week by the student to inform the patient of the progress of the training, collect the work and answer any questions
Interventions
Eligibility Criteria
You may qualify if:
- Sex: female
- Age less than or equal to 75 years
- Breast cancer stage I to III
- Chemotherapy and / or radiotherapy adjuvant completed
- Hormone treatments ongoing
You may not qualify if:
- Age over 75 years
- Breast cancer stage IV and O
- Anemia, Cardiac arrhythmia, asthma, hypertension or uncontrolled diabetes, coronary artery disease or severe respiratory disease, psycho-cognitive may disturb walking program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu BOONE, MD
CHU Amiens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
May 30, 2016
Study Start
February 18, 2013
Primary Completion
February 10, 2026
Study Completion
February 10, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02