NCT05433077

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 27, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

June 16, 2022

Last Update Submit

August 20, 2025

Conditions

Non-Metastatic Breast CarcinomaRemissionQuality of Life

Keywords

Non-metastatic Breast cancerSpa therapyremissionQuality of lifesupportive carePost-cancer rehabilitation

Outcome Measures

Primary Outcomes (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.

    6 months after inclusion

Secondary Outcomes (3)

  • Quality of life SF-36 (Global scores)

    up to 18 months

  • Quality of life SF-36 (Scores of the subscales)

    up to 18 months

  • Quality of life SF-36 by subgroups

    6 months after inclusion

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Thermes de Balaruc-les-Bains

Balaruc-les-Bains, 34540, France

Location

Thermes de Barbotan

Barbotan-les-Thermes, 32150, France

Location

Thermes de Cambo-les-Bains

Cambo-les-Bains, 64250, France

Location

Thermes de Capvern-les-Bains

Capvern, 65130, France

Location

Thermes de Contrexéville

Contrexéville, 88140, France

Location

Bains de Sarrailh

Dax, 40100, France

Location

Thermes d'Eugénie-les-Bains

Eugénie-les-Bains, 40320, France

Location

Thermes de Gréoux-les-Bains

Gréoux-les-Bains, 04800, France

Location

Thermes de La Léchère

La Léchère, 73261, France

Location

Thermes de la Roche-Posay

La Roche-Posay, 86270, France

Location

Thermes de Luxeuil-les-Bains

Luxeuil-les-Bains, 70300, France

Location

Thermes de Molitg-les-Bains

Molitg-les-Bains, 66500, France

Location

Thermes de Saint Amand-les-Eaux

Saint-Amand-les-Eaux, 59230, France

Location

Thermes de Soucéo

Saint-Paul-lès-Dax, 40990, France

Location

Thermes de Saujon

Saujon, 17600, France

Location

Related Publications (4)

  • 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.

    PMID: 23352440BACKGROUND

  • 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.

    PMID: 24882370BACKGROUND

  • 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.

    PMID: 28427084BACKGROUND

  • 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.

    PMID: 39881247DERIVED

Study Officials

  • Xavier DURANDO, Dr/Pr

    Centre Jean Perrin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 27, 2022

Study Start

June 27, 2022

Primary Completion

February 28, 2025

Study Completion

December 30, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)