Antalgic Effects of Well-being Treatments in Cancer Care | NCT05493150

Studies
Antalgic Effects of Well-being Treatments in Cancer Care

NCT05493150

Sponsor

Centre Hospitalier de Valence

Status

Completed

Last Update Posted

Sep 8, 2025Actual

Enrollment

180Actual

Phase

Not provided

Conditions

Cancer
Cancer Pain

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2020Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Jul 6, 2022

First Submission Date that Met QC Criteria

Aug 5, 2022

First Posted Date

Aug 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.

Detailed Description

Contrary to supportive care, well-being care is imperfectly assessed. Well being care (WBC) consist on complementary programs, with no real consensus. Very few studies have rigorously evaluated its benefits

The objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, Sophrology and singing) provided in a healthcare facility

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assesment	numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	1 immediately before well being treatment
Pain assesment	numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	1 immediately after well being treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all type of cancer treated at the general Hospital of Valence
patient agree to participate on Well being session: foot reflexology, socio-aesthetics, Sophrology and singing
Age ≥ 18 years
Affiliation to a Social security system
Patient who has given written consent signed before any specific procedure of the protocol

Exclusion Criteria:

Patient under guardianship, deprived of liberty, safeguard of justice
Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator)
Refusal to participate in research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients treated for a cancer in CH Valence, agree to participate on one of the 4 Well being treatments: foot reflexology, socio-aesthetics, sophrology and singing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ch Valence		Valence	Drome	26953	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided