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

Primary Purpose

Cancer of Colon, Cancer, Lung, Cancer, Breast

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SOCIO-AESTHETICS care
Sponsored by
Centre Hospitalier de Valence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Colon focused on measuring SOCIO-AESTHETIC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    group A: well-being care performed by SOCIO-AESTHETICS

    group B: control

    Arm Description

    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) 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

    Outcomes

    Primary Outcome Measures

    Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
    Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome

    Secondary Outcome Measures

    pain EVA
    EVA (0-10) higher scores mean worse outcome.
    Anxiety
    HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Centre Hospitalier de Valence
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06035731
    Brief Title
    Evaluation of the Medical Service by Socio-aesthetics in Oncology
    Acronym
    RCT-SE
    Official Title
    Evaluation of the Medical Service by Socio-aesthetics in Oncology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2026 (Anticipated)
    Study Completion Date
    April 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier de Valence

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer of Colon, Cancer, Lung, Cancer, Breast, Cancer Prostate, Cancer Pain, Anxiety Depression
    Keywords
    SOCIO-AESTHETIC

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    open label, randomized, controlled, multicenter intervention study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A: well-being care performed by SOCIO-AESTHETICS
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    group B: control
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    SOCIO-AESTHETICS care
    Intervention Description
    SOCIO-AESTHETICS well being care performed by qualify person
    Primary Outcome Measure Information:
    Title
    Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
    Description
    Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    pain EVA
    Description
    EVA (0-10) higher scores mean worse outcome.
    Time Frame
    up to 12 weeks
    Title
    Anxiety
    Description
    HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guillaume Guillaume
    Phone
    +33475752555
    Email
    gbuiret@ch-valence.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    sandrine Beauchard, MD
    Phone
    +33475818870
    Email
    sbeauchard@ch-valence.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guillaume Guillaume
    Organizational Affiliation
    CH Valence
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Evaluation of the Medical Service by Socio-aesthetics in Oncology

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