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

Last updated: March 24, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Dysfunctional Uterine Bleeding

Head And Neck Cancer

Treatment

Ecologic Momentary Assessment (EMA)

Clinical Study ID

NCT05850663
Quadshot mHealth
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years and older

  • Written informed consent and any locally-required authorization obtained from thepatients prior to performing any protocol-related procedures, including screeningevaluations

  • Pathologically (histologically or cytologically) proven diagnosis of cancer of thehead and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknownprimary) or Gynecologic cancers (cervical and endometrial)

  • Locally recurrent or metastatic HNC or Gyn cancer not deemed amenable tocurative-intent salvage therapy, in whom at least six months have passed since theirprior 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

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 thetreating radiation oncologist, cannot be reirradiated safely without excess risk ofsevere toxicity given prior radiation dose to critical structures.

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

  • Female patients who are pregnant

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Ecologic Momentary Assessment (EMA)
Phase:
Study Start date:
April 20, 2025
Estimated Completion Date:
August 30, 2026

Study Description

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.

Connect with a study center

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

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