Anxiety Depression, Cancer, Breast, Cancer, Lung, Cancer of Colon, Cancer Pain, Cancer Prostate
Conditions
Keywords
SOCIO-AESTHETIC
Brief summary
the 3-year randomized controlled RCT-SE study aims to investigate Socio-aesthetics well being care on quality of life, pain and anxiety. The primary objective is to show that socio-aesthetics well being care improves quality of life during cancer treatment, compared to self care administration of dermo-cosmetics products The secondary objectives are to show that socio-aesthetics well being care significantly reduced anxiety and pain compared to self care administration of dermo-cosmetics products
Detailed description
Socio-aesthetics care is the delivery appropriate beauty care in a population weakened by a physical, psychological and/or social attack. this well-being care is imperfectly assessed with few data from randomized controlled trials. The RCT-STudy is a randomized, controlled, multicenter, open label, intervention study that will be conducted among 400 patients treated with chemotherapy for breast, prostate, colon and lung cancer. Patients will be randomly assigned to one of the two arms of the study according to a 1:1 ratio: * Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetic person, with dermo-cosmetics product defined, during 4 consecutive chemotherapy administrations . * Group B (control) will apply the same dermo-cosmetics products themselves (self-care) without intervention of socio-aesthetic, during 4 consecutive chemotherapy administrations 12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure N°5: * Pain assessed by Eva * Anxiety assessed by HADS * impact of socio-aesthetics care care , assessed by Patient Centricity Questionnaire (PCQ) (0 -110) Data will be recorded using an e-CRF. patient will be recruited over 3 years and will be followed up for 3 months. Hypothesis: Socio-aesthetics session significantly improves quality of life and reduced pain and anxiety compared to self care administration of dermo-cosmetics products
Interventions
OTHERSOCIO-AESTHETICS care
SOCIO-AESTHETICS well being care performed by qualify person
Sponsors
Centre Hospitalier de Valence
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
open label, randomized, controlled, multicenter intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 18 years old * treated with chemotherapy for lung , breast, colon or prostate cancer * Able to understand, read, and write French, * Affiliated with a social security scheme, * Having dated and signed an informed consent.
Exclusion criteria
* Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study, * Deprived of their liberty by court or administrative decision,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care | up to 12 weeks | Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain EVA | up to 12 weeks | EVA (0-10) higher scores mean worse outcome. |
| Anxiety | up to 12 weeks | HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGuillaume Guillaume
CH VALENCE
Outcome results
None listed