An interventional study of Ecologic Momentary Assessment (EMA) in Head and Neck Cancer, Gynecologic Cancer and Cervical Cancer, sponsored by University of Oklahoma. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Other
The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.
This study will involve patients who have been diagnosed with head and neck or gynecologic cancers and are receiving radiation treatments via the QUAD shot regimen. It is a single arm pilot trial designed to provide information on the ease of use, feasibility, and perceived usefulness of a smartphone application to monitor symptoms and quality of life during cancer treatment, as well as assess barriers to care and perceptions of the smartphone app.
Patients will download the study app onto their personal smartphone, if the phone is compatible with the app, or a study smartphone will be loaned to them. The smartphone app will first ask patients to complete the 15-25 minute baseline survey, followed by one daily brief survey that ask about symptoms, quality of life, and barriers for 75 days. At the end of this period, the smartphone app will prompt the patient to complete a final survey, followed by a brief in-person or telephone interview to assess opinions about the app. Patients' symptoms, treatment effects, medication adherence, pain, quality of life, and general barriers to care will be assessed with questionnaires to measure the impacts of the mobile health-based assessment platform. Results from this study will be for research only and will not impact treatment decisions.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
Browse Head and Neck Neoplasms studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
Patients will receive one EMA (Ecologic Momentary Assessment) per day for approximately 75 days, through the provided smart phone application.
Other: Ecologic Momentary Assessment (EMA)
EMA enables measurement of phenomena in real-time, natural settings. EMA data will be used to identify moments of high distress, assess cancer treatment side effects, and assess barriers to care. The EMA methodology used in this study will ask about current emotional, physical, behavioral, and social states. The EMAs will consist of time-based sampling (i.e. a daily dairy), which will be prompted and initiated by the phone.
Patient satisfaction via qualitative interview and app based EMAs
Proportion of patients satisfied with the mHealth app. Patient satisfaction will be collected during the follow-up qualitative interview, and data will be analyzed using qualitative methods. The intervention will be deemed feasible if at least 75% of patients report that the app is easy to use and useful. Specifically, we will describe how often the app is used to measure symptoms, treatment effects, medication adherence, and pain, as well as HR-QOL and barriers to care.
Time frame: 75 days
Patient perceptions of mHealth platform
Proportion of patients who deem the mHealth app easy to use and useful. To gauge patient perception of mHealth platform with feedback from qualitative interview and app based EMAs. The final survey asks questions on the patients' thoughts, feelings, and opinions about the intervention they received over the course of the study.
Time frame: 75 days
Feasibility of intervention
Proportion of patients who complete the phone-based surveys. Feasibility of the study will be determined by the proportion of participants who complete \>/=75% of phone-based assessments. The app allows for the completion rate to be quantified.
Time frame: 75 days
Patient-reported barriers to care
Proportion of patients who report barriers to care as indicated by feedback from qualitative interview and app based EMAs.
Time frame: 75 days
Changes in weekly FACT-HN, FACT-Cx, or FACT-En scores over time
Proportion of changes in weekly FACT-HN, FACT-Cx, or FACT-En scores over time as indicated by feedback from qualitative interview and app based EMAs.
Time frame: 75 days
Completion rates of daily questionnaires
Proportion of daily questionnaires completed as indicated by EMA completion rate.
Time frame: 75 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Oklahoma