RECRUITING

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

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Conditions

Carcinoma of Unknown PrimaryClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Head and Neck CarcinomaMetastatic Malignant Neoplasm in the Uterine CervixPathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Stage I Hypopharyngeal Carcinoma AJCC v8Stage I Nasopharyngeal Carcinoma AJCC v8Stage II Hypopharyngeal Carcinoma AJCC v8Stage II Laryngeal Cancer AJCC v8Stage II Nasopharyngeal Carcinoma AJCC v8Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Nasopharyngeal Carcinoma AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

Quick Facts

Study Start:2016-12-29
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03010150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical metastases
  2. * Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer
  3. * 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
  4. * Are stage II-IVb for laryngeal cancer
  5. * Are stage I-IVb for hypopharyngeal
  6. * Are stage I-IVb for nasopharyngeal cancer
  7. * Have stage I-III unknown primary cancer with cervical
  1. * Have other cancer diagnoses, except non-melanoma skin cancer
  2. * Had treatment for previous head and neck cancer or radiation to the head and neck
  3. * Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
  4. * Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

Contacts and Locations

Principal Investigator

Eileen H Shinn
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Eileen H Shinn, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-29
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2016-12-29
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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