Improving Symptom Self-management in Adolescents & Young Adults With Cancer (CSCAT2)
2017年12月20日 更新者：Virginia Commonwealth University
This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates an image of the symptoms the participant is experiencing, for improving symptom self-management in adolescents and young adults with cancer.
In this one-group trial, participants will complete the C-SCAT and use it during two clinic visits with their oncology providers.
調査の概要
詳細な説明
Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs) with cancer.
Strategies are needed to help AYAs manage symptoms.
The investigators developed the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs create a picture of their symptoms using images and text on an iPad app.
The resulting image shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has potential to support AYA's symptom self-management.
Facilitating the self-management process, including self-efficacy, self-regulation behaviors, and patient-provider communication, is essential for improving symptom outcomes.
研究の種類
観察的
入学 (実際)
30
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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Missouri
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Kansas City、Missouri、アメリカ、64108
- The Childrens Mercy Hospital
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University/Massey Cancer Center
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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
15年～29年 (子、大人)
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
全て
サンプリング方法
非確率サンプル
調査対象母集団
pediatric and adult oncology clinics at the Virginia Commonwealth University Health System (VCUHS).
Patients and parents of minor patients will be approached as inpatients or as outpatients at Massey Cancer Center Fellows Clinic and at the Pediatric Oncology Clinic.
説明
Inclusion Criteria:
- 15 to 29 years of age with a diagnosis of cancer (primary, relapsed/recurrent, refractory, progressive, or secondary malignancy) receiving myelosuppressive chemotherapy.
- Completion of at least one cycle of therapy for cancer and anticipated to have at least two additional cycles of myelosuppressive chemotherapy as part of the treatment plan.
- Ability to speak and understand English as required to complete the C-SCAT and study measures.
- Ability to use a tablet computer.
Exclusion Criteria:
- Cognitive and/or physical inabilities to complete the proposed study measures as determined by self--report, parent report of minor, or medical chart.
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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C-SCAT
C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.
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C-SCAT is an investigator developed app that is delivered via an iPad.
The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale.
The recently updated version includes two additional symptoms "feeling bloated" and "sexual dysfunction" that are included in the adult version of the MSAS.21
These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.
他の名前：
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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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Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.
時間枠：Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
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Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
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Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.
時間枠：Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
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Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
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Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.
時間枠：Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)
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Semi-structured interviews to address how using the C-SCAT impacts self-regulation behaviors, such as self-monitoring, reflective thinking, and decision-making
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Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)
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Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.
時間枠：After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
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After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
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Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.
時間枠：After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
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After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
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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。
捜査官
- 主任研究者：Suzanne W. Ameringer, Ph.D.、Virginia Commonwealth University
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)
2016年11月1日
一次修了 (実際)
2017年10月25日
研究の完了 (実際)
2017年10月25日
試験登録日
最初に提出
2016年11月6日
QC基準を満たした最初の提出物
2016年11月22日
最初の投稿 (見積もり)
2016年11月28日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月22日
QC基準を満たした最後の更新が送信されました
2017年12月20日
最終確認日
2017年12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。