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進行性腎細胞癌における治療関連毒性のソフトウェアモニタリング

2026年4月15日 更新者：Chunkit Fung、University of Rochester

Carevive ソフトウェアを使用した進行性腎細胞癌 (RCC) 患者における経口標的薬剤および免疫療法による治療関連毒性のモニタリング、単群第 II 相実現可能性研究

治療関連の毒性を監視し、これらの症状に対するセルフケア管理計画を作成する Carevive ソフトウェアが、転移性腎細胞癌 (RCC) 患者に導入可能かどうかを判断する。 さらに、治療関連の毒性、生活の質、苦痛のレベル、服薬遵守に関する予備データの収集にも使用されます。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

21

段階

  • 適用できない

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

  • アメリカ
    • New York
      • Rochester、New York、アメリカ、14642
        • University of Rochester - Wilmot Cancer Institute

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

18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

説明

包含基準:

  • 転移性疾患の病理学的証拠またはX線写真による証拠を伴う、組織学的に確認されたサブタイプの腎細胞癌の診断
  • 18歳以上
  • 参加しているウィルモットがんセンターの腫瘍学者は、候補者が進行性RCCの治療のために経口標的療法または免疫療法のいずれかを開始する必要があると判断しました。これは一次治療またはその後の治療に適用できます。
  • 書面によるインフォームドコンセントを提供できる
  • 英語に堪能であり、読み書きができると自己申告している
  • アクティブな電子メール アドレスを持っているか、テキスト メッセージを受信できるスマート デバイスにアクセスできる必要があります

除外基準:

  • 女性は授乳できない
  • インターネットに定期的にアクセスできない
  • ウィルモットがんセンターの主治医の定期診察のために 3 ～ 4 か月ごとに予約を取ることができない
  • 以前に研究に参加していた被験者は、治療が変更された場合に再登録することはできません。

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

  • 主な目的：支持療法
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Carevive ソフトウェアの使用
進行性腎細胞癌 (RCC) 患者における経口標的療法または免疫療法による副作用の報告と管理を、Carevive ソフトウェアを介して行います。
他の：Carevive ソフトウェア
この研究では、Carivive はオンライン調査を完了できるように被験者へのリンクを提供します。 調査は研究の最初の 12 週間は毎週行われ、その後は隔週で行われます。 質問は主にがん治療による副作用に焦点を当てており、服薬遵守や医療利用に関するいくつかの質問も含まれます。 調査完了後、被験者には薬物関連毒性に対する自宅での自己管理オプションを含むケアプランが与えられます。

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
Number of Participants Who Submitted at Least One Carevive Survey
時間枠：From enrollment through 48 weeks
Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
From enrollment through 48 weeks
Percentage of Carevive Surveys Completed Per Participant
時間枠：From enrollment through 48 weeks
Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
From enrollment through 48 weeks
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
時間枠：From enrollment through 48 weeks
Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
From enrollment through 48 weeks
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
時間枠：From enrollment through 48 weeks
Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
From enrollment through 48 weeks
System Usability Scale (SUS) Score for Carevive Software
時間枠：From enrollment through 48 weeks
Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100. Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points). We calculated the SUS point for each participant who completed the survey.
From enrollment through 48 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
時間枠：From enrollment through 48 weeks
The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
From enrollment through 48 weeks
Distress Level Assessed by NCCN Distress Thermometer
時間枠：From enrollment through 48 weeks
The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress. Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
From enrollment through 48 weeks
Health Care Utilization Assessment
時間枠：From enrollment through 48 weeks
Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
From enrollment through 48 weeks
Participants Reporting Diarrhea
時間枠：From enrollment through 48 weeks
Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Nausea
時間枠：From enrollment through 48 weeks
Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Vomiting
時間枠：From enrollment through 48 weeks
Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Fatigue
時間枠：From enrollment through 48 weeks
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy. Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Rash
時間枠：From enrollment through 48 weeks
Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Abdominal Pain
時間枠：From enrollment through 48 weeks
Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Mouth Sores
時間枠：From enrollment through 48 weeks
Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Cough
時間枠：From enrollment through 48 weeks
Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Shortness of Breath
時間枠：From enrollment through 48 weeks
Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Participants Reporting Anorexia
時間枠：From enrollment through 48 weeks
Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks. Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
From enrollment through 48 weeks
Clinician Reported Diarrhea
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Nausea
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Vomiting
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Fatigue
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Rash
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Abdominal Pain
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Mouth Sores
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Cough
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Shortness of Breath
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks
Clinician Reported Anorexia
時間枠：From enrollment through 48 weeks
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma. Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks. Responses were categorized as Yes, No, or Unknown based on clinician assessment. These data are presented as longitudinal assessments of symptom occurrence over time. Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
From enrollment through 48 weeks

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

University of Rochester

協力者

National Cancer Institute (NCI)

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)

2019年7月24日

一次修了 (実際)

2025年2月14日

研究の完了 (実際)

2025年2月14日

試験登録日

最初に提出

2017年7月18日

QC基準を満たした最初の提出物

2017年7月24日

最初の投稿 (実際)

2017年7月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月7日

QC基準を満たした最後の更新が送信されました

2026年4月15日

最終確認日

2025年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • UGUK 17036
  • UG1CA189961 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

進行性腎細胞がんの臨床試験

Carevive ソフトウェアの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Ghana

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

購読する