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NCT05850663 | RECRUITING | Head and Neck Cancer

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

University of Oklahoma

Brief Summary:

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

Condition or disease

Head and Neck Cancer

Intervention/treatment

Ecologic Momentary Assessment (EMA)

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Quality of Life Assessment of Hypofractionated Radiotherapy in Recurrent Head and Neck Cancer: CPC-CT Pilot
Actual Study Start Date : 2024-11-30
Estimated Primary Completion Date : 2025-08-30
Estimated Study Completion Date : 2026-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

Location Details

NCT05850663

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How to Participate

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Locations

RECRUITING

United States, Oklahoma

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104