Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
調査の概要
詳細な説明
At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.
Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.
Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Masonic Cancer Center, University of Minnesota
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team
- Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Must be at least 18 years of age
Exclusion Criteria:
- Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)
- Undergo partial laryngectomy, when open or endoscopic
- Have previously altered anatomy of the upper aerodigestive tract
- Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)
- Have prior malignant disease of the upper aerodigestive tract
- Have prior radiation therapy to the head and neck region
- Metastatic disease
- Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Patients Treated with Laryngectomy
Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
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Patients Treated with Chemoradiation
Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Swallowing Function Scores
時間枠：12 months after Treatment
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The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment.
Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.
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12 months after Treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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General Quality of Life
時間枠：PreTreatment, 6 Months and 12 Months After Treatment
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The SF-12 Quality of Life questionnaire will be used to assess general health status.
The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).
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PreTreatment, 6 Months and 12 Months After Treatment
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Speech Assessment
時間枠：PreTreatment, 6 Months and 12 Months After Treatment
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Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index.
The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.
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PreTreatment, 6 Months and 12 Months After Treatment
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Head and Neck Quality of Life
時間枠：PreTreatment, 6 Months and 12 Month After Treatment
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The University of Washington Quality of Life Assessment Questionnaire will be administered.
This questionnaire is specifically designed to capture head and neck cancer-specific function.
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PreTreatment, 6 Months and 12 Month After Treatment
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Bevan Yueh, MD, MPH、Masonic Cancer Center, University of Minnesota
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。