Cancer of ColonRCT-SENCT06035731
Evaluation of the Medical Service by Socio-aesthetics in Oncology
A study testing SOCIO-AESTHETICS care in people with Cancer of Colon and Cancer, Lung, run by Centre Hospitalier de Valence at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Colon, Cancer, Lung, Cancer, Breast
- What is being tested?
- SOCIO-AESTHETICS care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- 15 May 2024to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
3 sites in 1 country.
About this study
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
Read the 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
- Conditions
- Cancer of Colon, Cancer, Lung, Cancer, Breast, Cancer Prostate, Cancer Pain, Anxiety Depression
- Being tested
- SOCIO-AESTHETICS care
- Keywords
- SOCIO-AESTHETIC
- Medical subject headings
- Colonic Neoplasms, Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOCIO-AESTHETICS careOther
SOCIO-AESTHETICS well being care performed by qualify person
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: SOCIO-AESTHETICS care |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
Measured: up to 12 weeks
Secondary outcomes (2)
pain EVA
EVA (0-10) higher scores mean worse outcome.
Measured: up to 12 weeks
Anxiety
HADS: Hospital Anxiety and Depression Scale (0-42) higher scores mean worse outcome.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 May 2024
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label, randomized, controlled, multicenter intervention study
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Guillaume, Principal investigator, CH VALENCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035731
- Sponsor's protocol ID
- RIPH-CHV-13
- Acronym
- RCT-SE
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Medical Service by Socio-aesthetics in Oncology
- ClinicalTrials.gov ID
- NCT06035731
- Acronym / sponsor ID
- RCT-SE / RIPH-CHV-13
- Conditions
- Cancer of Colon, Cancer, Lung, Cancer, Breast, Cancer Prostate, Cancer Pain, Anxiety Depression
- Keywords
- SOCIO-AESTHETIC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenceUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, randomized, controlled, multicenter intervention study
| Arm | Type | Receives |
|---|---|---|
| group A: well-being care performed by SOCIO-AESTHETICS | Experimental | Other: SOCIO-AESTHETICS careGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOCIO-AESTHETICS careSOCIO-AESTHETICS well being care performed by qualify person | Other | group A: well-being care performed by SOCIO-AESTHETICS |
Primary outcome
Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care
Time frame: up to 12 weeks
Patient Centricity Questionnaire (PCQ): (0-110) higher scores mean better outcome
2 secondary outcomes
pain EVA
Time frame: up to 12 weeks
Anxiety
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Guillaume principal investigator
CH VALENCE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOCIO-AESTHETICS care in people with Cancer of Colon and Cancer, Lung, run by Centre Hospitalier de Valence at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Centricity Questionnaire (PCQ): Patient reported outcome: impact of supportive care (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.