Clinical trial · Observational
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer
NCT03010150CI-TRIAL-00108323recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial uses blood tests and questionnaires to study how well participants with head and neck cancer that has spread to other places in the body adhere to swallowing exercises to prevent future disease. Using blood tests to study cytokines (proteins related to the immune system) may help doctors learn if certain levels of cytokines affect whether or not side effects occur and if they put participants at risk for future disease. Questionnaires may help doctors learn about the reasons head and neck cancer participants may or may not follow the swallowing exercises that they are asked to perform after receiving radiation treatments.
Conditions
Conditions (31)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
| Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | — | UNRESOLVED | — |
| Metastatic Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Uterine Cervix | — | UNRESOLVED | — |
| Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (blood tests, questionnaires)
- description
- Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Adherence to swallowing exercises
- timeFrame
- Up to 6 months
- description
- The primary analytic approach is to use linear mixed models to determine whether illness perceptions significantly predict adherence 6 months. The study will estimate and test the illness perception subscale scores' relationship to adherence using a linear mixed model. In the model, the dependent variable is the patient's self-reported adherence score and independent variables include illness perception, follow-up assessment time point and other covariates such as demographic and medical variables, depression, pain, fatigue, emotional coping, objective coping, appraisal of coping, stress, and lack of social well-being.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases * Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer * Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant metastasis * Are stage II-IVb for laryngeal cancer * Are stage I-IVb for hypopharyngeal * Are stage I-IVb for nasopharyngeal cancer * Have stage I-III unknown primary cancer with cervical Exclusion Criteria: * Have other cancer diagnoses, except non-melanoma skin cancer * Had treatment for previous head and neck cancer or radiation to the head and neck * Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy) * Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)
References
Publications (1)
- DERIVEDShinn EH, Garden AS, Peterson SK, Leupi DJ, Chen M, Blau R, Becerra L, Rafeedi T, Ramirez J, Rodriquez D, VanFossen F, Zehner S, Mercier PP, Wang J, Hutcheson K, Hanna E, Lipomi DJ. Iterative Patient Testing of a Stimuli-Responsive Swallowing Activity Sensor to Promote Extended User Engagement During the First Year After Radiation: Multiphase Remote and In-Person Observational Cohort Study. JMIR Cancer. 2024 Feb 28;10:e47359. doi: 10.2196/47359. PMID 38416544