Clinical trial NCT02785861: Step by Step After Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: hormonal therapy
walking
fatigue
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Pinto and colleagues, for a walking level from 55 to 65% HRmax, estimated a reduction of fatigue in post treatment. Supervised exercise show greater adherence to short-term practice at home. However, there are a growing number of studies suggesting a practice at home, the most activity being walking. The authors do not justify the choice of the type of supervision. But physical activity with a professional and / or group in a specific place definitely has different effects in relation to practice at home. Segal and his colleagues in 2001 for the first time wished to compare the two types of supervision. The results are in favor of supervised exercise. The training was identical. However, to answer the five weekly sessions requested, the patient group had to complete two supervised practice sessions at home. So, the investigators really can not quantify the difference in impact between home practice and supervised practice. In a meta-analysis, Velthuis and colleagues conclude a significant difference in fatigue during treatment for a supervised aerobic exercise against a home that does not show significant difference. If the training is the same in both situations, the investigators should not find any difference in physiologic responses. However, the psychological impact can vary from one situation to another.

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.

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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: fatigue of the patient with QLQC-30
timeFrame: 6 weeks
Secondary outcomes:
measure: Global Quality of life with QLQC-30
timeFrame: 6 weeks
measure: Activity level with IPAQ
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Mathieu BOONE, MD
role: PRINCIPAL_INVESTIGATOR
References: