Clinical trial NCT05850663: Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer
Official title: Quality of Life Assessment of Hypofractionated Radiotherapy in Recurrent Head and Neck Cancer: CPC-CT Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Gynecologic Cancer
Cervical Cancer
Endometrial Cancer
Keywords: Radiation Therapy
Mobile Health
QUADSHOT
Quality of Life
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

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) or Gynecologic cancers (cervical and endometrial)
* Locally recurrent or metastatic HNC or Gyn cancer 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

Primary outcomes:
measure: Patient satisfaction via qualitative interview and app based EMAs
timeFrame: 75 days
measure: Patient perceptions of mHealth platform
timeFrame: 75 days
Secondary outcomes:
measure: Feasibility of intervention
timeFrame: 75 days
measure: Patient-reported barriers to care
timeFrame: 75 days
measure: Changes in weekly FACT-HN, FACT-Cx, or FACT-En scores over time
timeFrame: 75 days
measure: Completion rates of daily questionnaires
timeFrame: 75 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
References: