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

Trial Title: Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

NCT ID: NCT05850663

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
Radiation Therapy
Mobile Health
QUADSHOT
Quality of Life

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Ecologic Momentary Assessment (EMA)
Description: 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.
Arm group label: Ecological Momentary Assessments (EMAs)

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

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Stephenson Cancer Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Lead Nurse

Phone: 405-271-8777
Email: SCC-IIT-Office@ouhsc.edu

Investigator:
Last name: Christina Henson, MD
Email: Principal Investigator

Start date: November 30, 2024

Completion date: August 30, 2026

Lead sponsor:
Agency: University of Oklahoma
Agency class: Other

Source: University of Oklahoma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05850663