Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment (PACTHE-VR)

August 20, 2025 updated by: Centre Jean Perrin

Real Life Pacthe : Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment

The PACThe - Real life project is a post-therapeutic support and rehabilitation for women in complete remission of breast cancer in a thermal environment. It consists of a 3 weeks spa treatment for patients in remission of breast cancer. This stay in spa treatment will be an adapted "post-cancer" support and has the main objective of showing a lasting improvement in the quality of life following the program offered to women following their breast cancer treatments.

The evaluation of the quality of life will be done using the SF-36 self-questionnaire which will be completed by the patients 5 times (inclusion visit, end of the spa stay, 6 months post-cure, 12 months post-cure and 18 months post-cure).

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Post-cancer rehabilitation has developed over the past twenty years. Among the support care put in place, there are in particular thermal cures. On the prescription of a doctor, they represent a medical treatment consisting in exploiting the thermal waters in order to help the recovery of patients.

Several studies have been carried out on the subject, in which it has been shown that spa treatments improve physical and emotional well-being, quality of life and also limit the occurrence of treatment-related toxicities.

The PACThe study, conducted in the thermal spas of Châtel-Guyon, Mont-Dore and Vichy and whose promoter was the Center Jean Perrin, showed that thermal cures significantly improved depression, the quality of sleep as well as quality of life of patients in remission from breast cancer. Following these conclusive results, the CNETh and the UNCAM agreed to set up a post-cancer rehabilitation program covered at 50% by social security, in multiple thermal centers in France. At the same time, the CNETh set up the PACThe-real-life study, which would back up this post-cancer program, in order to confirm and verify the reproducibility of the results of the PACThe study at the national level.

The PACThe-real-life study is an observational RIPH 3 type study with longitudinal cohort follow-up during a post-therapeutic support and rehabilitation program in a spa environment. This study plans to recruit patients aged 20 to 75, in remission from breast cancer, and whose treatment has been completed.

The cures contain a complete program of approximately 3 weeks, composed not only of baths, but also of physical activity, aquagymnastics, massage and physiotherapy, as well as dietary and psychological monitoring. All this allowing the physical, social, professional, family and psychological reconstruction of the patients.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Balaruc-les-Bains, France, 34540
        • Thermes de Balaruc-les-Bains
      • Barbotan-les-Thermes, France, 32150
        • Thermes de Barbotan
      • Cambo-les-Bains, France, 64250
        • Thermes de Cambo-les-Bains
      • Capvern, France, 65130
        • Thermes de Capvern-les-Bains
      • Contrexéville, France, 88140
        • Thermes de Contrexéville
      • Dax, France, 40100
        • Bains de Sarrailh
      • Eugénie-les-Bains, France, 40320
        • Thermes d'Eugénie-les-Bains
      • Gréoux-les-Bains, France, 04800
        • Thermes de Gréoux-les-Bains
      • La Léchère, France, 73261
        • Thermes de La Léchère
      • La Roche-Posay, France, 86270
        • Thermes de la Roche-Posay
      • Luxeuil-les-Bains, France, 70300
        • Thermes de Luxeuil-les-Bains
      • Molitg-les-Bains, France, 66500
        • Thermes de Molitg-les-Bains
      • Saint-Amand-les-Eaux, France, 59230
        • Thermes de Saint Amand-les-Eaux
      • Saint-Paul-lès-Dax, France, 40990
        • Thermes de Soucéo
      • Saujon, France, 17600
        • Thermes de Saujon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 to 75, suffering from breast cancer and having been treated with chemotherapy and/or radiotherapy, currently in complete remission who are going to undergo a spa treatment as part of the post-cancer programme.

Description

Inclusion Criteria:

  • Patient suffering from breast cancer
  • Treated by chemotherapy and/or radiotherapy
  • Absence of residual or progressive disease
  • Patient whose treatment has ended (except hormone therapy)
  • Able to give informed consent to participate in research
  • Affiliation to a Social Security scheme

Exclusion Criteria:

  • Cancer in progressive or metastatic phase
  • Disabled patient
  • Serious personality or eating behavior disorders (craving, bulimia, etc.)
  • Thinness (BMI < 18.5 kg.m-2)
  • Severe to massive obesity (BMI > 35 kg.m-2)
  • Refusal to participate
  • Contraindication to physical activity (of cardiovascular origin or linked to a pathology of the musculoskeletal system), lymphedema is not a contraindication
  • Participation in another clinical study
  • Insufficient knowledge or understanding of the French language making it impossible to correctly complete a self-administered quality of life questionnaire or to answer a dietary questionnaire
  • The medical contraindications of spa treatment validated by the French Society of Hydrology and Climatology will be applied and are as follows:
  • Severe alterations in general condition (evolving infectious state, renal or hepatic insufficiency, cirrhosis, respiratory insufficiency, etc.)
  • Severe or acute ulcerative colitis and Crohn's disease
  • Severe immunodeficiencies
  • Recent phlebitis
  • Hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life SF-36
Time Frame: 6 months after inclusion
Global score of the short-form 36 (SF-36) quality of life questionnaire. The score goes from 0 to 100. Higher is the score, better is the quality of life.
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life SF-36 (Global scores)
Time Frame: up to 18 months
Global scores of the short-form 36 (SF-36) quality of life questionnaire. The score goes from 0 to 100. Higher is the score, better is the quality of life.
up to 18 months
Quality of life SF-36 (Scores of the subscales)
Time Frame: up to 18 months
Scores of the subscales of the short-form 36 (SF-36) questionnaire. The score goes from 0 to 100. Higher is the score, better is the quality of life.
up to 18 months
Quality of life SF-36 by subgroups
Time Frame: 6 months after inclusion
Global scores of the SF-36 quality of life questionnaire by subgroups (BMI, age, menopausal status, level of education, precariousness (evaluated via the EPICES score)). The score goes from 0 to 100. Higher is the score, better is the quality of life.
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

Conseil National des Etablissements Thermaux

Investigators

  • Study Director: Xavier DURANDO, Dr/Pr, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00171-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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