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Step by Step After Cancer (SBSAC)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
supervision of physical activity
distance supervised physical activity
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring hormonal therapy, walking, fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

supervised practice

distance supervised physical activity

Arm Description

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

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 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

Outcomes

Primary Outcome Measures

fatigue of the patient with QLQC-30

Secondary Outcome Measures

Global Quality of life with QLQC-30
Activity level with IPAQ

Full Information

First Posted
May 23, 2016
Last Updated
May 30, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02785861
Brief Title
Step by Step After Cancer
Acronym
SBSAC
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
hormonal therapy, walking, fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supervised practice
Arm Type
Experimental
Arm Description
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
Arm Title
distance supervised physical activity
Arm Type
Experimental
Arm Description
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 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
Intervention Type
Behavioral
Intervention Name(s)
supervision of physical activity
Intervention Type
Behavioral
Intervention Name(s)
distance supervised physical activity
Primary Outcome Measure Information:
Title
fatigue of the patient with QLQC-30
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Global Quality of life with QLQC-30
Time Frame
6 weeks
Title
Activity level with IPAQ
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu BOONE, MD
Phone
+33 3 22 45 62 26
Email
boone.mathieu@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, MD
Phone
+33 3 22 45 62 26
Email
boone.mathieu@chu-amiens.fr

12. IPD Sharing Statement

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Step by Step After Cancer

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