Symptom Management to Improve Completion of Patient-reported Outcome Measures
Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
1. To test the effectiveness of the intervention's enhanced patient reported outcome (PRO) monitoring strategy (offer of nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms and evidence-based self-management strategies for elevated symptoms) versus the active control (receipt of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures) on PRO monitoring reach and penetration [PRO assessment completion] over 6 months.
SECONDARY OBJECTIVES:
- Test the extent to which any differences in PRO monitoring reach and penetration between intervention and control arms at month 6 are explained by patient's symptom management self-efficacy and expectancy at month 3 (potential mechanisms).
- Test the extent to which any differences in PRO monitoring reach and penetration at month 6 between intervention and control arms differ according to patient, disease and treatment characteristics (e.g., age, site and stage of cancer, concurrent radiation therapy).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Eric Adjei Boakye, PhD
- 電話番号:313-874-6218
- メール:eadjei1@hfhs.org
研究場所
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health
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コンタクト:
- Eric Adjei Boakye, PhD
- 電話番号:(313) 874-6218
- メール:eadjei1@hfhs.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1) Adults (≥18 years) with a diagnosis of a malignancy of head and neck or lung cancers.
- 2) Scheduled to start infusion systemic therapy in the next 4 weeks or have started infusion systemic therapy in the past 4 weeks.
- 3) Able to read and understand English.
- 4) Cognitively oriented to person, place and time (determined by recruiter).
Exclusion Criteria:
- 1) Unable to read and understand English.
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
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Arm I (PROMIS assessment)
Patients will be invited to complete Patient-Reported Outcomes Measurement Information System (PROMIS) assessments via MyChart.
If MyChart assessments are not completed, patients will be asked to complete them on a tablet in the waiting room during clinic visit.
Patients receive reminders to complete their eCheck-in and questionnaires including PROMIS 48hrs before their visit.
Upon patients-reported outcomes assessment completion, we will send them a "Thank You" message acknowledging their completion.
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Patients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room.
The scores are recorded in their health record and available for review by health care providers.
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実験的:Arm II (PROMIS assessment, PRO-CTCAE assessments, self-management strategies)
Patients will receive text message via Computerized Intervention Authoring System (CIAS) and invited to complete Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) items for the most prevalent symptoms.
When patients complete the patient reported outcomes assessment, we will immediately send them a message acknowledging receipt of symptoms, a summary of symptoms and a thank you message.
Patients receive a copy of the Symptom Management Toolkit and when a symptom is rated at 2 or higher in severity (common PRO-CTCAE dimension for 8 symptoms) or if diarrhea is rated at 2 or higher in frequency (the only PRO-CTCAE dimension for this symptom), patients will be sent a follow-up text message directing them to specific relevant sections of the Toolkit.
When any symptom is rated at 3 or higher, patients will be asked to contact their healthcare provider about this symptom.
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Patients will be offered to complete Patient-Reported Outcomes Measurement Information System (PROMIS) measures of symptoms and physical function prior to their scheduled clinic appointments via MyChart or on a tablet in the clinic's waiting room.
The scores are recorded in their health record and available for review by health care providers.
Assessments of additional symptoms from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be offered via Computerized Intervention Authoring System (CIAS).
For elevated symptoms, patients will be directed to use evidence-based self-management strategies from the printed Symptom Management Toolkit.
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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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Reach of patient reported outcome (PRO) assessment completion
時間枠:6 months
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The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
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6 months
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Penetration of patient reported outcome (PRO) assessment completion
時間枠:6 months
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The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
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6 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 19934
- K01CA308852-01A1 (その他の識別子:NCI)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国FDA規制機器製品の研究
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