NCT05907551

Brief Summary

Cancer treatments can trigger cutaneous side-effects, as well as nail and hair toxicities. When related to drug treatment, this iatrogeny depends on the type of drug, its dosage and individual susceptibility. Although these dermatological adverse events are rarely serious, they can significantly alter patients' quality of life, and may even necessitate the introduction of curative treatment. The impact of these side effects can be mitigated by the use of dermo-cosmetic products and aesthetic solutions. However, most of this supportive care is not reimbursed by the health insurance system, representing a source of inequalities in access to healthcare for cancer patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

June 8, 2023

Last Update Submit

August 21, 2023

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs

    4 items questionnaires

    at inclusion

  • Describe patients' knowledges regarding dermo-cosmetics and aesthetic solutions that can attenuate cutaneous side-effects, nail and hair toxicities induced by anticancer drugs

    10 items questionnaires

    at inclusion

Secondary Outcomes (4)

  • Describe patients' socio-economic profile to assess equity regarding access to dermo-cosmetics and aesthetic solutions

    at inclusion

  • Correlate patients' knowledge level depending on tumoral location

    at inclusion

  • Correlate patients' knowledge level depending on received treatment

    at inclusion

  • Correlate patients' knowledge level depending on treatment phase

    at inclusion

Study Arms (7)

Patients with Digestive System Cancer

Other: Questionnaires

Patients with Head and Neck Cancer

Other: Questionnaires

Patients with Breast Cancer

Other: Questionnaires

Patients with Nervous System Tumors

Other: Questionnaires

Patients with Urological Cancer

Other: Questionnaires

Patients with Lung Cancer

Other: Questionnaires

Patients with Gynecologic Cancer

Other: Questionnaires

Interventions

QuestionnairesOTHER

25-items questionnaire

Patients with Breast CancerPatients with Digestive System CancerPatients with Gynecologic CancerPatients with Head and Neck CancerPatients with Lung CancerPatients with Nervous System TumorsPatients with Urological Cancer

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will enroll patients with solid tumors in 7 different cohorts according to tumor location (30 patients per location)

You may qualify if:

  • Age \> 18 years
  • Patients with solid tumors (eligible localization include: digestive system, Head and Neck, Breast, Brain, Lung Tumors, Urological and Gynecologic cancers)
  • Patients able to read and understand French
  • Patients that has expressed their consent and with signed consent form

You may not qualify if:

  • Minor or patients placed under guardianship or supervision
  • Patients unable to read French
  • Patients placed under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nelly ETIENNE-SELLOUM, PharmD

    Institut de cancérologie Strasbourg Europe

    STUDY CHAIR

Central Study Contacts

Manon VOEGELIN

CONTACT

(0)3 68 33 95 23promotion-rc@icans.eu

Claire VIT

CONTACT

(0)3 88 25 85 29promotion-rc@icans.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 18, 2023

Study Start

July 25, 2023

Primary Completion

October 25, 2023

Study Completion

October 25, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

FR(1)