NCT06953245

Brief Summary

This study evaluates patient-reported experiences of radiation dermatitis in patients with breast cancer undergoing radiotherapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress51%
Apr 2025Jun 2027

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

April 23, 2025

Last Update Submit

March 31, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient experiences with radiation dermatitis

    Themes will be collected during a brief interview following agreement to participate. Common themes related to physical, emotional, and social impacts of radiation dermatitis will be categorized and quantified to provide a comprehensive understanding of the patient experience.

    Baseline (at enrollment)

Study Arms (1)

Observational

Patients complete a survey on study, completed as a brief interview.

Other: Non-Interventional Study

Interventions

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer who are currently undergoing or recently completed radiotherapy

You may qualify if:

  • Adults ≥ 18
  • Patients diagnosed with breast cancer
  • Currently undergoing or recently completed radiotherapy
  • Willing to provide verbal/oral consent
  • Willing to be recorded as they are answering the survey questions

You may not qualify if:

  • Persons \< 18
  • Inability to provide verbal consent
  • Non-English speakers (unless translations are available)
  • Not willing to be recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kimberly S. Corbin, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 1, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations