Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05433077 Active, sans recrutement

Titre

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

Type

Observational

Pathologie

Tumeurs du sein

Phase

Promoteur

Centre Jean Perrin (Voir sur ClinicalTrials)

Date de début

juin 2022

Date de fin

novembre 2026

Dernière mise à jour

29 juin 2024

Résumé

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).

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Bains de Sarrailh - 40100 - Dax - France				Contact (sur clinicalTrials)
Thermes de Balaruc-les-Bains - 34540 - Balaruc-les-Bains - France				Contact (sur clinicalTrials)
Thermes de Barbotan - 32150 - Barbotan-les-Thermes - France				Contact (sur clinicalTrials)
Thermes de Cambo-les-Bains - 64250 - Cambo-les-Bains - France				Contact (sur clinicalTrials)
Thermes de Capvern-les-Bains - 65130 - Capvern - France				Contact (sur clinicalTrials)
Thermes de Contrexéville - 88140 - Contrexéville - France				Contact (sur clinicalTrials)
Thermes de Gréoux-les-Bains - 04800 - Gréoux-les-Bains - France				Contact (sur clinicalTrials)
Thermes de La Léchère - 73261 - La Léchère - France				Contact (sur clinicalTrials)
Thermes de la Roche-Posay - 86270 - La Roche-Posay - France				Contact (sur clinicalTrials)
Thermes de Luxeuil-les-Bains - 70300 - Luxeuil-les-Bains - France				Contact (sur clinicalTrials)
Thermes de Molitg-les-Bains - 66500 - Molitg-les-Bains - France				Contact (sur clinicalTrials)
Thermes de Saint Amand-les-Eaux - 59230 - Saint Amand-les-Eaux - France				Contact (sur clinicalTrials)
Thermes de Saujon - 17600 - Saujon - France				Contact (sur clinicalTrials)
Thermes de Soucéo - 40990 - Saint-Paul-lès-Dax - France				Contact (sur clinicalTrials)
Thermes d'Eugénie-les-Bains - 40320 - Eugénie-les-Bains - France				Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT05433077 - Real Life Pacthe : Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment (PACTHE-VR)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut