Clinical trial · Observational
Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment
Real Life Pacthe : Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment
NCT05433077CI-TRIAL-00094135PACTHE-VRactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Metastatic Breast Carcinoma | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Remission | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Quality of life SF-36
- timeFrame
- 6 months after inclusion
- description
- 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.
Secondary outcomes (3)
- measure
- Quality of life SF-36 (Global scores)
- timeFrame
- up to 18 months
- description
- 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.
- measure
- Quality of life SF-36 (Scores of the subscales)
- timeFrame
- up to 18 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDKwiatkowski 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 23352440
- BACKGROUNDMourgues 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 24882370
- BACKGROUNDKwiatkowski 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 28427084
- DERIVEDGodiveau 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 39881247