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

Centre Jean Perrin

Status: Active, not recruiting

Conditions: Remission; Quality of Life; Non-Metastatic Breast Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT05433077

2022-A00171-42

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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