Quality of Life in Patients With Hepatocellular Carcinoma
Validation of Questionnaire Module for Quality of Life and Analysis of Its Association With Clinical Outcomes; a Cohort Study in Patients With Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC, the prognosis of HCC is still poor even after curative treatment.
Performance status has shown to be associated with long-term survival and prognosis in patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver Cancer (BCLC) staging system. Recently, the researches on health-related quality of life (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were developed.
The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) is a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However, there is no consensus whether it would be appropriate to adopt HRQL as a prognostic variable in HCC staging system. Moreover, there is limited information available about the impact of patients' HRQL on long-term outcome in patients with HCC.
Thus, in this study, the researchers will investigate whether HRQL can be an important factor in HCC staging system by testing the reliability and clinical validity of FACT-Hep, EORTC QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL with treatment efficacy, recurrence and survival outcome. Lastly, the investigators will suggest the suitable questionnaire module for patients with HCC.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Seoul、大韓民国、138-736
- 募集
- Asan Medical Center
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コンタクト：
- Ju Hyun Shim, MD, PhD
- 電話番号：+82-2-3010-3190
- メール：s5854@medimail.co.kr
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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:
- 18 years of age or older
- Diagnosis of HCC
- Ability to speak, read, and write Korean
- Patient is able and willing to give informed consent
Exclusion Criteria:
- Evidence of cognitive impairment or psychiatric disturbance
- Other concurrent malignancy
- Patients involved in other clinical studies
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
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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Clinical validity of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
時間枠：Baseline
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The FACT-Hep questionnaire consists of 18-item Hepatobiliary Subscales and 27-item FACT-G, which contains physical (7 items), social (7 items), emotional (6 items), and functional scales (7 items).
Hepatobiliary Subscale is scored 0-72, FACT-G is scored 0-108, and FACT-Hep is scored 0-180.
EORTC QLQ-HCC 18 is an 18-item questionnaire designed to be used along with the 30-item EORTC QLQ-C30.
EORTC QLQ-HCC 18 questionnaire includes 8 symptom scales such as fatigue, jaundice, nutrition, pain, fever, abdominal swelling, sexual interest, and body image.
Each item is scored 0-100 according to the EORTC guidelines.
NFHSI-18 consists of 18-item scales, and each item is scored 0-4, yielding a total between 0 and 72.
The investigators will test the validity by using the correlation and comparison of all of the questionnaire scores at baseline.
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Baseline
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Reliability of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
時間枠：Baseline and at least 6 hours later
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Patients will complete the questionnaires at baseline and then will respond to the follow-up surveys at least 6 hours later the first assessment.
The investigators will examine reliability by assessing test-retest reliability of each survey after measuring the scores of questionnaires at two assessment points.
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Baseline and at least 6 hours later
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二次結果の測定
結果測定 |
時間枠 |
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Recurrence rates
時間枠：upto 3 years
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upto 3 years
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Death rates
時間枠：upto 3 years
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upto 3 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ju Hyun Shim, MD, PhD、Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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。
肝細胞癌の臨床試験
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