- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07852949
Understanding the Role of MyCareGorithm as a Visual Digital Platforms in Cancer Treatment Education and Patient Comprehension of Oncology Treatment Plans
The purpose of this research study is to learn if a digital communication tool can improve how well patients with head and neck cancer and their caregivers understand the disease and treatment plan after their first consultation visit with the doctor/nurse practitioner.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
The primary objective of this pilot study is to determine whether use of a novel digital visual communication tool improves patient understanding and satisfaction with their initial multidisciplinary consultation for head and neck and prostate cancer. Specifically, the study seeks to answer the scientific question:
• Do at least 75% of newly diagnosed head and neck and prostate cancer patients report being "satisfied" (≥4 positive responses on a 6-item survey) after use of the digital communication tool, and is this proportion significantly greater than 50%?
Secondary Objectives:
Caregiver Understanding and Satisfaction
• What proportion of caregivers of newly diagnosed patients report satisfaction with their understanding of the patient's disease and treatment after using the tool, and how confident can we be in this estimate (95% Clopper-Pearson CI)?
Provider Experience and Communication Effectiveness
• What proportion of providers report satisfaction (≥5 positive responses on a 7-item survey) with the tool's ability to improve communication efficiency and consultation quality for patients they treated?
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Steven J Frank, MD
- Phone Number: (713) 563-3601
- Email: sjfrank@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT MD Anderson
-
Contact:
- Steven J Frank, MD
- Phone Number: 713-563-3601
- Email: sjfrank@mdanderson.org
-
Principal Investigator:
- Steven Frank, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients
- Adults aged 18 to 100 years.
- Diagnosed with head and neck cancer (all histologies included).
- Receiving treatment for head and neck and prostate cancer at MDACC
- Able to speak and understand English
Caregivers
- Adults (≥18 years old).
- Identified as a caregiver to a patient who meets the above patient inclusion criteria.
- Able to speak and understand English.
Providers
- Doctors or nurse practitioners practicing in the field of radiation oncology and actively participating in initial consultations for patients with head and neck cancer and prostate cancer.
- Must complete the provider survey after the consultation.
Exclusion Criteria:
Patients
- Individuals without a diagnosis of head and neck cancer or prostate cancer.
- Patients who do not speak English (since the digital tool is not translated).
Caregivers
- Adults who are not caregivers of the eligible patient
- Caregivers who do not speak English (tool not translated).
Providers
- Doctors or nurse practitioners not practicing in the field of radiation oncology and not part of the initial consultation process.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient/Caregiver: Use of MyCareGorithm
Following use of the digital visual communication tool by the provider, patients and any accompanying caregivers will be asked to complete their surveys via REDCap. Providers will complete their survey immediately after the consultation with each participating patient, also via REDCap. Each survey requires approximately 5 minutes to complete. No follow-up surveys or repeat administrations are planned. |
A 6-item structured questionnaire with Yes/No response options, followed by one open-ended free-text question. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven J Frank, MD, UT MD Anderson
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Head and Neck Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 2026-1108
- NCI-2026-07264 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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