Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer

NCT03010150 | Recruiting

• 3 other identifiers: 2016-0597NCI-2018-01260R21DE019954
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carcinoma of Unknown Primary; Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Metastatic Head and Neck Carcinoma; Metastatic Malignant Neoplasm in the Uterine Cervix; Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Stage I Hypopharyngeal Carcinoma AJCC v8; Stage I Nasopharyngeal Carcinoma AJCC v8; Stage II Hypopharyngeal Carcinoma AJCC v8; Stage II Laryngeal Cancer AJCC v8; Stage II Nasopharyngeal Carcinoma AJCC v8; Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Nasopharyngeal Carcinoma AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Nasopharyngeal Carcinoma AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVA Hypopharyngeal Carcinoma AJCC v8; Stage IVA Laryngeal Cancer AJCC v8; Stage IVA Nasopharyngeal Carcinoma AJCC v8; Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Hypopharyngeal Carcinoma AJCC v8; Stage IVB Laryngeal Cancer AJCC v8; Stage IVB Nasopharyngeal Carcinoma AJCC v8; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (3)

• Adherence to swallowing exercises

  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.

  Up to 6 months

• Illness perceptions

  The study's statistical tool is mediation analysis: the independent variables are the sickness behaviors (depression, fatigue, pain); the mediators are the cytokine levels, and the outcome variable is illness perception. The study will test the mediator effects based on the product of coefficients method, rather than the classical Baron \& Kenny causal steps tests, since the former approach has better statistical power. The study will conduct both single-mediator analysis for each of the mediators, and multiple-mediator analysis with all mediators in the mediating process

  Up to 6 months

• Effect of social support on coping

  The moderating effect of social support on coping and appraisal of coping is the statistical equivalent of testing the two-way interaction between these variables and the social support variable. Multivariate linear regression will be used, in which the dependent variable is appraisal of coping at 6 months follow-up, and independent variables include the emotion-focused coping and action-focused sub scales, social support, and their two-way interactions. In the regression, the study will control for baseline variables. In addition, we will also apply the linear mixed model to investigate the moderating effect of these variables longitudinally. The mixed model naturally accounts for the correlation of repeated measures at baseline and 6 months follow-up.

  Up to 6 months

Study Arms (1)

Observational (blood tests, questionnaires)

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.

Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Provide blood samples

Observational (blood tests, questionnaires)

Questionnaire Administration OTHER

Ancillary studies

Observational (blood tests, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with head and neck cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Shinn 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 DERIVED

Related Links

• M D Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples obtained from participants

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Laryngeal Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Nasopharyngeal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Eileen H Shinn

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 4, 2017
• Study Start: December 29, 2016
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)