- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07306130
Consensus on Skin Care in Breast Cancer Patients
Study Overview
Status
Conditions
Detailed Description
Study Overview
This study is a non-interventional, observational expert consensus project designed to develop region-appropriate guidelines for skin care management in breast cancer patients undergoing systemic therapies, radiotherapy, or surgical treatment. Although numerous international guidelines address cancer-related skin toxicities, most are derived from Western populations and do not fully reflect regional differences in skin phototypes (Fitzpatrick III-VI), environmental factors, product availability, and care pathways common in the Middle East and North Africa (MENA) region. Because breast cancer patients frequently experience treatment-related dermatologic adverse events that affect quality of life and treatment adherence, a structured expert consensus is required to standardize preventive and therapeutic skin-care practices across oncology and dermatology settings.
Study Design
This study follows a Modified Delphi methodology, The Delphi process will include 2-3 iterative rounds:
Round 1 - Qualitative Item Generation
Experts will complete an open-ended questionnaire covering:
baseline skin-care recommendations (cleansing, moisturization, photoprotection); management of radiotherapy-induced dermatitis; chemotherapy- and targeted-therapy-related skin toxicities (xerosis, papulopustular rash, nail changes, photosensitivity); surgical wound and scar care; use of dermocosmetics and supportive products during cancer therapy; safety considerations for Fitzpatrick III-VI skin; contraindicated products or procedures (exfoliants, retinoids, lasers, waxing);
patient-education strategies; follow-up schedules and referral pathways; regional barriers (product availability, cultural factors, climate impact). Responses will undergo thematic analysis to produce structured statements.
Round 2 - Quantitative Consensus Rating
Panelists will rate the consolidated statements using a 9-point Likert scale (1 = inappropriate, 9 = appropriate), assessing clinical utility, safety, feasibility, and applicability to breast cancer care in the MENA region.
Optional Round 3
Only statements without clear consensus will undergo a third round. Experts will review anonymized group statistics (median, distribution spread) and re-rate remaining borderline items, allowing refinement of near-agreement topics.
Expert Panel Selection
Experts will be eligible if they meet at least two of the following criteria:
- ≥5 years of clinical experience in dermatology, oncology, or supportive cancer care;
- Recognized national or regional lecturer, trainer, or key opinion leader;
- Peer-reviewed publications in dermatology, oncology, supportive care, or cancer survivorship;
- Active practice within Egypt or other MENA countries.
The targeted panel size is 15-25 experts, ensuring representation across dermatology, radiation oncology, medical oncology, nursing, and survivorship care.
Statistical Analysis For each item, the following will be calculated: median, interquartile range, interpercentile range (IPR), IPR adjusted for symmetry (IPRAS), and the Disagreement Index. Items will be categorized by agreement level and summarized for publication. Subgroup analyses (e.g., GCC vs North Africa) may be performed.
Ethical Considerations This study does not involve patients, clinical interventions, or personal health information. Participation is voluntary. Expert responses are anonymized. No foreseeable risks are associated with participation, and the study qualifies as minimal-risk, non-interventional research.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Venus Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical Expertise: Must be a practicing healthcare professional (HCP) with a minimum of [e.g., 5-10] years of clinical experience in breast cancer management, supportive care, or oncology-related dermatology.
- Geographic and Practice Diversity: Representation from different geographical regions and practice settings (e.g., academic centers, community hospitals) to ensure broad applicability of the recommendations.
Availability and Willingness to Participate: Must formally agree to commit to the entire multi-round Delphi process (typically 2-4 rounds) within the specified timeline.
Exclusion Criteria:
- Inability or unwillingness to complete Delphi rounds.
- Lack of clinical experience with breast cancer patients.
- Industry representatives without direct clinical practice.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Oncodermatology-Focused Skincare
A cohort of dermatology and aesthetic medicine experts from the MENA region participating in a Modified Delphi process to develop consensus recommendations on Skin care in Breast Cancer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Achievement of Consensus on Skin Care in Breast Cancer patients
Time Frame: 6-12 weeks
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The final set of evidence-based and/or expert-supported statements, interventions, or practice recommendations for skin care in breast cancer patients that reach a pre-defined threshold of agreement among the expert panel.
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6-12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breast Cancer-Venus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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