Assessing Quality of Life in Patients with Recurrent Head and Neck Cancer Receiving Radiation
Quality of Life Assessment of Hypofractionated Radiotherapy in Recurrent Head and Neck Cancer: CPC-CT Pilot
This study is testing a mobile app to see if it can help people with recurrent head and neck cancer track their symptoms and quality of life while they receive radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05850663 on ClinicalTrials.gov |
What this trial studies
This study examines the use of a mobile health application to monitor symptoms and quality of life in patients with recurrent head and neck or gynecologic cancers undergoing radiation treatment. Participants will use the app to complete a baseline survey and daily symptom assessments over 75 days, providing insights into their treatment experience. The study aims to evaluate the feasibility and perceived usefulness of this mobile platform, as well as identify barriers to care. Results will inform future research but will not influence treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with recurrent head and neck or gynecologic cancers who are not eligible for curative treatment.
Not a fit: Patients who have received prior radiation therapy within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance symptom management and improve quality of life for patients undergoing radiation therapy.
How similar studies have performed: Other studies utilizing mobile health applications for symptom monitoring in cancer patients have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oklahoma City, Oklahoma
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: SCC IIT Office
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 1-405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.