SOCIO-AESTHETICS care
OtherSOCIO-AESTHETICS well being care performed by qualify person
NCT Number: NCT06035731
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Antoine Lacassagne, Nice, France
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:
12 Evaluations will be conducted between chemotherapy cure N° 2 and chemotherapy cure N°5:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SOCIO-AESTHETICS well being care performed by qualify person
Time frame: up to 12 weeks
Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
Time frame: up to 12 weeks
EVA (0-10) higher scores mean worse outcome.
Time frame: up to 12 weeks
HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.
Centre Hospitalier de Valence
Other
Acronym: RCT-SE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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