RCT-SE: Evaluation of the Medical Service by Socio-aesthetics in Oncology

• Sponsor: Centre Hospitalier de Valence (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06035731
• Collaborator: (none)
• Enrollment: 400
• Arms: 2
• Anticipated Duration (Months): 41

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of Colon; Cancer, Lung; Cancer, Breast; Cancer Prostate; Cancer Pain; Anxiety Depression	Other: SOCIO-AESTHETICS care	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: open label, randomized, controlled, multicenter intervention studyopen label, randomized, controlled, multicenter intervention study
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of the Medical Service by Socio-aesthetics in Oncology
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A: well-being care performed by SOCIO-AESTHETICS 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	Other: SOCIO-AESTHETICS care; SOCIO-AESTHETICS well being care performed by qualify person
No Intervention: group B: control 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. pain EVA [up to 12 weeks]

   EVA (0-10) higher scores mean worse outcome.

2. Anxiety [up to 12 weeks]

   HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier de Valence

Investigators

• Principal Investigator: Guillaume Guillaume, CH Valence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier de Valence
• ClinicalTrials.gov Identifier: NCT06035731
• Other Study ID Numbers: RIHP-CHV-13
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier de Valence: SOCIO-AESTHETIC
• Additional relevant MeSH terms: Breast Neoplasms; Lung Neoplasms; Colonic Neoplasms; Cancer Pain

Study Results

No Results Posted as of Sep 13, 2023