Effects of socio-aesthetic care on anxiety in cancer patients undergoing chemotherapy
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
This study tests if special care focused on appearance and social support can help reduce anxiety in cancer patients going through chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Valence) |
| Trial ID | NCT05649852 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of socio-aesthetic care on the anxiety levels of cancer patients receiving chemotherapy. Patients will be assessed at six different points: at the start of treatment, during the first four cycles of chemotherapy, and at the end of the treatment. The study focuses on patients with various types of cancer who are undergoing chemotherapy every 14 or 21 days. The primary measure will be the change in State Anxiety scores from pre-treatment to post-treatment.
Who should consider this trial
Good fit: Ideal candidates include chemotherapy-naïve cancer patients who are fluent in French and can complete questionnaires.
Not a fit: Patients who have previously received socio-aesthetic care or those unable to understand the study information may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety levels in cancer patients undergoing chemotherapy.
How similar studies have performed: While the specific approach of socio-aesthetic care in this context is novel, similar interventions have shown promise in reducing anxiety in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles; * Chemotherapy naïve patient; * Patient speaking and understanding French and able to complete the questionnaires; * Patient having been informed and having signed an informed consent form to participate in the study. Exclusion Criteria: * Patient who has already benefited from socio-aesthetic care; * Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.); * Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding; * Patient participating in another clinical trial, or in a period of exclusion from another clinical trial; * Patient not benefiting from a social security scheme.
Where this trial is running
Valence
- Hôpital Privé Drôme Ardèche — Valence, France (Recruiting)
Study contacts
- Study coordinator: Louis DOUBLET, MD
- Email: l.doublet@ramsaygds.fr
- Phone: 4 75 75 87 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.