Trial Summary
What is the purpose of this trial?The purpose of this research study is to test the ability of a mobile device application (MyCap) to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy.
Eligibility Criteria
This trial is for individuals with head and neck cancers who are undergoing radiation therapy and experiencing radiation dermatitis, a type of skin rash. Participants should be willing to use the MyCap app to report on their condition.Inclusion Criteria
Ability to understand and the willingness to sign an IRB-approved informed consent document in English
I am 18 years old or older.
Able and willing to complete electronic toxicity and quality of life assessments in the MyCap application using their personal mobile device
+2 more
Exclusion Criteria
I have early-stage vocal cord cancer and will be treated with targeted radiation only.
I have had radiation therapy on my head or neck before.
I have scleroderma or lupus and need medication for it.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Therapy
Participants receive radiation therapy for head and neck cancer while using KeraStat cream to assess radiation dermatitis
Up to 2 years
Weekly visits during radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after radiation therapy, including weekly assessments for 4 weeks post-therapy
4 weeks
Weekly visits for 4 weeks post radiation therapy
Patient Engagement and Satisfaction Assessment
Participants engage with the MyCap app for data collection and provide feedback on satisfaction with the M-PART framework
4 weeks after completion of radiation therapy
Participant Groups
The study tests KeraStat cream's effectiveness in treating acute radiation dermatitis. It involves clinical assessments, using the cream, reporting symptoms via MyCap app, and providing feedback through a phone interview.
1Treatment groups
Experimental Treatment
Group I: M-PART Assessment via MyCapExperimental Treatment4 Interventions
Assessment through the MyCap app to assess radiation dermatitis with the use of Kerastat cream.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator