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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A: well-being care performed by SOCIO-AESTHETICS | Experimental | Group A will benefit from 4 sessions of well being care performed by a qualified socio-aesthetics, during 4 consecutive chemotherapy administrations. Patients included will have following interventions : quality of life: PCQ Pain: EVA Anxiety: HADS |
|
| group B: control | No Intervention | Group B (control) will apply the dermo-cosmetic products themselves (self-care) without intervention of the socio-aesthetician, during 4 consecutive chemotherapy administrations. quality of life: PCQ Pain: EVA Anxiety: HADS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOCIO-AESTHETICS care | Other | SOCIO-AESTHETICS well being care performed by qualify person |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care | Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pain EVA | EVA (0-10) higher scores mean worse outcome. | up to 12 weeks |
| Anxiety | HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Guillaume | CH VALENCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | France | ||||
| AP HP |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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open label, randomized, controlled, multicenter intervention study
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| up to 12 weeks |
| Paris |
| France |
| Chru Tours | Tours | France |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |