Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Quality of Life Assessment of Hypofractionated Radiotherapy in Recurrent Head and Neck Cancer: CPC-CT Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850663
• Other study ID #: Quadshot mHealth
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: June 2024
• Source: University of Oklahoma
• Contact: SCC IIT Office
• Phone: 1-405-271-8777
• Email: SCC-IIT-Office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.

Description:

This study will involve patients who have been diagnosed with neck or head cancer 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations

• Pathologically (histologically or cytologically) proven diagnosis of cancer of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary)

• Locally recurrent or metastatic HNC not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received

• Must have evaluable lesion per RECIST v1.1

• Patients agree to provide their smoking history prior to registration

• ECOG performance status of 0-2

Exclusion Criteria:

• Prior radiotherapy to the region of the study cancer within less than 6 months

• Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.

• Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)

• Female patients who are pregnant

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	75 days
Primary	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.	75 days
Secondary	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.	75 days
Secondary	Patient-reported barriers to care	Proportion of patients who report barriers to care as indicated by feedback from qualitative interview and app based EMAs.	75 days
Secondary	Changes in weekly FACT-HN scores over time	Proportion of changes in weekly FACT-HN scores over time as indicated by feedback from qualitative interview and app based EMAs.	75 days
Secondary	Completion rates of daily questionnaires	Proportion of daily questionnaires completed as indicated by EMA completion rate.	75 days