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Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

Primary Purpose

Non Metastatic Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dietaty education, physical training, physiotherapy and SPA cares
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Metastatic Breast Cancer focused on measuring breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • breast cancer
  • treatment including a chemotherapy
  • in complete remission
  • last treatment in the last 9 months before inclusion
  • signed consent

Exclusion Criteria:

  • metastatic disease
  • relapse
  • women enable to have physical activity
  • heart disease or any pathology preventing physical activity

Sites / Locations

  • Centre Jean Perrin
  • Pole Santé-République

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

dietary and physical training

control

Arm Description

12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers

dietary counseling by a dietetician in the anticancer hospital

Outcomes

Primary Outcome Measures

Quality of life (SF36)
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.

Secondary Outcome Measures

Anxiety/depression scores (HAD)
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
Weight and morphometric measures
Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
Sleep quality
6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.
economic figures
health related costs, health insurance costs, social costs

Full Information

First Posted
February 22, 2012
Last Updated
December 23, 2015
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT01563588
Brief Title
Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
Official Title
Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Enrollment lasted longer than expected and expected number of patients could not be matched in time.
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer. The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Metastatic Breast Cancer
Keywords
breast cancer, chemotherapy, first line treatment, treatments include a chemotherapy, last treatment not performed more than 9 months earlier

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dietary and physical training
Arm Type
Experimental
Arm Description
12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
Arm Title
control
Arm Type
No Intervention
Arm Description
dietary counseling by a dietetician in the anticancer hospital
Intervention Type
Behavioral
Intervention Name(s)
dietaty education, physical training, physiotherapy and SPA cares
Intervention Description
12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
Primary Outcome Measure Information:
Title
Quality of life (SF36)
Description
Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.
Time Frame
one year after inclusion
Secondary Outcome Measure Information:
Title
Anxiety/depression scores (HAD)
Description
HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.
Time Frame
inclusion, 6, 12, 18, 24, 36 months
Title
Weight and morphometric measures
Description
Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups
Time Frame
inclusion, 6, 12, 18, 24, 36 months
Title
Sleep quality
Description
6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.
Time Frame
inclusion, 6, 12, 18, 24, 36 months
Title
economic figures
Description
health related costs, health insurance costs, social costs
Time Frame
during 2 years after inclusion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: breast cancer treatment including a chemotherapy in complete remission last treatment in the last 9 months before inclusion signed consent Exclusion Criteria: metastatic disease relapse women enable to have physical activity heart disease or any pathology preventing physical activity
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
State/Province
Puy de Dome
ZIP/Postal Code
63011
Country
France
Facility Name
Pole Santé-République
City
Clermont-Ferrand
State/Province
Puy de Dome
ZIP/Postal Code
63100
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.cjp.fr/
Description
URL to Centre Jean Perrin main page

Learn more about this trial

Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

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