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

This study has been terminated.

(Enrollment lasted longer than expected and expected number of patients could not be matched in time.)

Sponsor:

Collaborator:

AFRETH - French association for hydrothermal research

Information provided by (Responsible Party):

Philippe Chollet, Centre Jean Perrin

ClinicalTrials.gov Identifier:

NCT01563588

First received: February 22, 2012

Last updated: March 23, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2012
Last Updated Date	March 23, 2012
Start Date ^ICMJE	May 2008
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2012)	Quality of life (SF36) [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01563588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 23, 2012)	Anxiety/depression scores (HAD) [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ] HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire. Weight and morphometric measures [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ] Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups Sleep quality [ Time Frame: inclusion, 6, 12, 18, 24, 36 months ] [ Designated as safety issue: No ] 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 [ Time Frame: during 2 years after inclusion ] [ Designated as safety issue: No ] health related costs, health insurance costs, social costs
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non Metastatic Breast Cancer
Intervention ^ICMJE	Behavioral: dietaty education, physical training, physiotherapy and SPA cares 12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
Study Arm (s)	Experimental: dietary and physical training 12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers Intervention: Behavioral: dietaty education, physical training, physiotherapy and SPA cares No Intervention: control dietary counseling by a dietetician in the anticancer hospital
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	251
Estimated Completion Date	October 2013
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01563588
Other Study ID Numbers ^ICMJE	PACThe, 2008-A 01606 - 49
Has Data Monitoring Committee	No
Responsible Party	Philippe Chollet, Centre Jean Perrin
Study Sponsor ^ICMJE	Centre Jean Perrin
Collaborators ^ICMJE	AFRETH - French association for hydrothermal research
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Jean Perrin
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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