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Non-Metastatic Breast CarcinomaPACTHE-VRNCT05433077

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

An observational study of Non-Metastatic Breast Carcinoma and Remission, run by Centre Jean Perrin at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
How many people
400 participants
Where
15 sitesFrance
Study dates
27 Jun 2022to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Thermes de Balaruc-les-Bains

    Balaruc-les-Bains, 34540

  • Thermes de Barbotan

    Barbotan-les-Thermes, 32150

  • Thermes de Cambo-les-Bains

    Cambo-les-Bains, 64250

  • Thermes de Capvern-les-Bains

    Capvern, 65130

  • Thermes de Contrexéville

    Contrexéville, 88140

  • Bains de Sarrailh

    Dax, 40100

  • Thermes d'Eugénie-les-Bains

    Eugénie-les-Bains, 40320

  • Thermes de Gréoux-les-Bains

    Gréoux-les-Bains, 04800

  • Thermes de La Léchère

    La Léchère, 73261

  • Thermes de la Roche-Posay

    La Roche-Posay, 86270

  • Thermes de Luxeuil-les-Bains

    Luxeuil-les-Bains, 70300

  • Thermes de Molitg-les-Bains

    Molitg-les-Bains, 66500

  • Thermes de Saint Amand-les-Eaux

    Saint-Amand-les-Eaux, 59230

  • Thermes de Soucéo

    Saint-Paul-lès-Dax, 40990

  • Thermes de Saujon

    Saujon, 17600

Other trials in France

About this study

Official title: 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).

Read the 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.

Keywords
Non-metastatic Breast cancer, Spa therapy, remission, Quality of life, supportive care, Post-cancer rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life SF-36

    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.

    Measured: 6 months after inclusion

Secondary outcomes (3)

  1. Quality of life SF-36 (Global scores)

    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.

    Measured: up to 18 months

  2. Quality of life SF-36 (Scores of the subscales)

    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.

    Measured: up to 18 months

  3. Quality of life SF-36 by subgroups

    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.

    Measured: 6 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start27 Jun 2022
  3. Primary completion28 Feb 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433077
Sponsor's protocol ID
2022-A00171-42
Acronym
PACTHE-VR
Status last verified
Oct 2026
First submitted
16 Jun 2022
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kwiatkowski F, Mouret-Reynier MA, Duclos M, Leger-Enreille A, Bridon F, Hahn T, Van Praagh-Doreau I, Travade A, Gironde M, Bezy O, Lecadet J, Vasson MP, Jouvency S, Cardinaud S, Roques CF, Bignon YJ. Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. Eur J Cancer. 2013 May;49(7):1530-8. doi: 10.1016/j.ejca.2012.12.021. Epub 2013 Jan 24.

    PubMed 23352440

  • Mourgues C, Gerbaud L, Leger S, Auclair C, Peyrol F, Blanquet M, Kwiatkowski F, Leger-Enreille A, Bignon YJ. Positive and cost-effectiveness effect of spa therapy on the resumption of occupational and non-occupational activities in women in breast cancer remission: a French multicentre randomised controlled trial. Eur J Oncol Nurs. 2014 Oct;18(5):505-11. doi: 10.1016/j.ejon.2014.04.008. Epub 2014 May 29.

    PubMed 24882370

  • Kwiatkowski F, Mouret-Reynier MA, Duclos M, Bridon F, Hanh T, Van Praagh-Doreau I, Travade A, Vasson MP, Jouvency S, Roques C, Bignon YJ. Long-term improvement of breast cancer survivors' quality of life by a 2-week group physical and educational intervention: 5-year update of the 'PACThe' trial. Br J Cancer. 2017 May 23;116(11):1389-1393. doi: 10.1038/bjc.2017.112. Epub 2017 Apr 20.

    PubMed 28427084

  • Godiveau M, Passildas J, Thivat E, Casile M, Pinard C, Giro A, Mouret-Reynier MA, Molnar I, Abrial C, Bouvier CE, Bignon YJ, Durando X. Post-therapeutic support and rehabilitation for breast cancer women in complete remission in a thermal resort: study protocol for the PACThe Real-Life conditions observational trial. BMC Cancer. 2025 Jan 29;25(1):174. doi: 10.1186/s12885-025-13524-2.

    PubMed 39881247

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Metastatic Breast Carcinoma and Remission, run by Centre Jean Perrin at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life SF-36 (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05433077, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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