Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy (PRISME)
2020年4月29日 更新者：Ipsen
Health Related Quality of Life and Multidimensional Evaluations of a Cohort of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy
The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.
調査の概要
詳細な説明
Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF).
Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet.
This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.
研究の種類
観察的
入学 (実際)
831
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Paris、フランス
- Ipsen Central Contact
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
サンプリング方法
非確率サンプル
調査対象母集団
Prostate Cancer subjects aged ≥ 60
説明
Inclusion Criteria:
- Subject presenting with histologically confirmed prostate cancer
- Subject of 60 years and older
- Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study
- Subject giving his written consent to participate in the study
- Subject able to complete questionnaires
Exclusion Criteria:
- Subject simultaneously participating in a clinical trial
- Subject who previously received a hormonal therapy during the last 6 months before inclusion
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
介入・治療 |
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Prostate cancer subjects 60-<70 years
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Subjects will be treated in accordance with usual medical practice during their participation in this study.
No additional assessments or tests will be required.
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Prostate cancer subjects 70-<75 years
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Subjects will be treated in accordance with usual medical practice during their participation in this study.
No additional assessments or tests will be required.
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Prostate cancer subjects ≥ 75 years
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Subjects will be treated in accordance with usual medical practice during their participation in this study.
No additional assessments or tests will be required.
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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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Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)
時間枠：Change from baseline at 6 months
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Evolution overall and in subgroups of age ([60-<70], [70- <75] and ≥ 75 years).
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Change from baseline at 6 months
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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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HRQOL Visual Analog Scale (VAS) score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Health status scores as evaluated by G8 questionnaire
時間枠：Baseline and 6 months
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Baseline and 6 months
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Overall condition VAS score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)
時間枠：Baseline and 6 months
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Subjects will be asked to indicate the score corresponding to their evaluation of their quality of life related to urinary symptoms in response to the following question 'If you were to live the rest of your life with this way of urinating, would you say you would be:' on a scale from 0 (very satisfied) to 6 (very upset).
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Baseline and 6 months
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Urinary function score VAS
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with their urinary function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Sexual function scores as evaluated by 3 questions on sexual domain of the Urolife Benign Prostatic Hyperplasia-Quality Of Life 9 (BPH-QoL 9) questionnaire
時間枠：Baseline and 6 months
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Baseline and 6 months
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Sexual function VAS score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with their sexual function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Cognitive status scores as evaluated by Mini Mental State (MMS)
時間枠：Baseline and 6 months
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Baseline and 6 months
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Memory VAS score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with memory (your capacity to remind events or persons you meet) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire
時間枠：Baseline and 6 months
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Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1.
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Baseline and 6 months
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Mood VAS score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with mood (your feeling of happiness, confidence and serenity) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)
時間枠：Baseline and 6 months
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Mobility will be scored as follows 'Bed or chair bound' = 0, 'Able to get out of bed/chair but does not go out' = 1, 'Goes out' = 2
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Baseline and 6 months
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VAS motricity score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with motricity (your ability to move by yourself in your home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'
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Baseline and 6 months
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Autonomy question
時間枠：Baseline and 6 months
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Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?'
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Baseline and 6 months
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Autonomy VAS score
時間枠：Baseline and 6 months
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Subjects evaluate level of satisfaction with autonomy (your ability to manage your life alone at home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
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Baseline and 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年3月9日
一次修了 (実際)
2020年2月28日
研究の完了 (実際)
2020年2月28日
試験登録日
最初に提出
2018年3月9日
QC基準を満たした最初の提出物
2018年4月23日
最初の投稿 (実際)
2018年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月30日
QC基準を満たした最後の更新が送信されました
2020年4月29日
最終確認日
2020年4月1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。
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