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

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Brief Title

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

Official Title

Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine whether illness perceptions significantly predict adherence to swallowing
      exercises at 6 months after the end of radiation.

      II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness
      perceptions are mediated by pro-inflammatory cytokines.

      III. To determine whether social support moderates the impact of coping on appraisal of
      coping.

      SECONDARY OBJECTIVES:

      I. As a secondary aim, to determine the feasibility and utility of cardiac impedance
      pre-ejection period measurement as a corollary measure for depression and distress.

      II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction
      which has developed by the 6-month follow-up.

      OUTLINE:

      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.

      After completion of study, participants are followed up periodically for up to 2 years.

Study Type

Observational

Primary Outcome

Adherence to swallowing exercises

Condition

Carcinoma of Unknown Primary

Intervention

Biospecimen Collection

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

471

Start Date

December 29, 2016

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eileen H Shinn, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03010150

Organization ID

2016-0597

Secondary IDs

NCI-2018-01260

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Eileen H Shinn, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

January 2021