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

Quality of Life Clinical Trial

— PACTHE-VR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05433077
• Other study ID #: 2022-A00171-42
• Status: Active, not recruiting
• Start date: June 27, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Non-Metastatic Breast Carcinoma
• Quality of Life
• Remission

Locations

Country	Name	City	State
France	Thermes de Balaruc-les-Bains	Balaruc-les-Bains
France	Thermes de Barbotan	Barbotan-les-Thermes
France	Thermes de Cambo-les-Bains	Cambo-les-Bains
France	Thermes de Capvern-les-Bains	Capvern
France	Thermes de Contrexéville	Contrexéville
France	Bains de Sarrailh	Dax
France	Thermes d'Eugénie-les-Bains	Eugénie-les-Bains
France	Thermes de Gréoux-les-Bains	Gréoux-les-Bains
France	Thermes de La Léchère	La Léchère
France	Thermes de la Roche-Posay	La Roche-Posay
France	Thermes de Luxeuil-les-Bains	Luxeuil-les-Bains
France	Thermes de Molitg-les-Bains	Molitg-les-Bains
France	Thermes de Saint Amand-les-Eaux	Saint Amand-les-Eaux
France	Thermes de Soucéo	Saint-Paul-lès-Dax
France	Thermes de Saujon	Saujon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Jean Perrin	Conseil National des Etablissements Thermaux

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 18 months
Secondary	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.	up to 18 months
Secondary	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.	6 months after inclusion