Clinical trial NCT05433077: Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment
Official title: Real Life Pacthe : Support and Post-therapeutic Rehabilitation for Women in Complete Remission of Breast Cancer in a Thermal Environment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Metastatic Breast Carcinoma
Remission
Quality of Life
Keywords: Non-metastatic Breast cancer
Spa therapy
remission
Quality of life
supportive care
Post-cancer rehabilitation
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Conseil National des Etablissements Thermaux
First posted: 2022-06-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life SF-36
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Quality of life SF-36 (Global scores)
timeFrame: up to 18 months
measure: Quality of life SF-36 (Scores of the subscales)
timeFrame: up to 18 months
measure: Quality of life SF-36 by subgroups
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Balaruc-les-Bains
country: France
facility: Thermes de Balaruc-les-Bains
city: Barbotan-les-Thermes
country: France
facility: Thermes de Barbotan
city: Cambo-les-Bains
country: France
facility: Thermes de Cambo-les-Bains
city: Capvern
country: France
facility: Thermes de Capvern-les-Bains
city: Contrexéville
country: France
facility: Thermes de Contrexéville
city: Dax
country: France
facility: Bains de Sarrailh
city: Eugénie-les-Bains
country: France
facility: Thermes d'Eugénie-les-Bains
city: Gréoux-les-Bains
country: France
facility: Thermes de Gréoux-les-Bains
city: La Léchère
country: France
facility: Thermes de La Léchère
city: La Roche-Posay
country: France
facility: Thermes de la Roche-Posay
city: Luxeuil-les-Bains
country: France
facility: Thermes de Luxeuil-les-Bains
city: Molitg-les-Bains
country: France
facility: Thermes de Molitg-les-Bains
city: Saint Amand-les-Eaux
country: France
facility: Thermes de Saint Amand-les-Eaux
city: Saint-Paul-lès-Dax
country: France
facility: Thermes de Soucéo
city: Saujon
country: France
facility: Thermes de Saujon
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, Dr/Pr
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.