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Symptom Management to Improve Completion of Patient-reported Outcome Measures

2026年7月28日 更新者:Eric Adjei Bokaye、Henry Ford Health System

Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)

In this clinical trial, patient reported outcome (PRO) assessment completion is compared between patients (undergoing systemic therapy for head and neck or lung cancer) who receive additional symptoms monitoring and evidence-based self-management strategies for those with elevated symptoms (intervention arm), and those who do not receive these (control arm). PRO measures are validated tools that capture health-related perspectives directly from the patient and are complementary to provider assessment. Timely completion of PRO assessments and symptoms management of moderate or severe symptoms are essential to improve quality of life and decrease unwanted health care utilization. However, only ~40% of patients complete PRO assessments in clinical settings. In addition, systemic therapy for cancer results in many symptoms (e.g., dry mouth, shortness of breath, constipation) not covered by the disease-general Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Patients in the control arm will receive the existing PROMIS assessments and a thank you message upon completion. Patients in the intervention arm will receive the PROMIS assessments in addition to nine Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) most prevalent symptoms, and evidence-based self-management strategies Handbook for those with elevated symptoms. Patients in the intervention arm will enter their symptoms in a SMS text and they will be directed to the handbook for strategies to manage their elevated symptoms using a digital platform-Computerized Intervention Authoring System (CIAS)-integrated within the Epic electronic health records. Information gathered has the potential to influence cancer care practices on a larger scale, shaping policies and clinical practices to improve health outcomes for cancer patients and reducing the burden of cancer-related symptoms.

調査の概要

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:

  1. 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).
  2. 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

介入

入学 (推定)

78

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

    • Michigan
      • Detroit、Michigan、アメリカ、48202
        • Henry Ford Health
        • 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

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

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

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: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
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.
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.
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.
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.

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
Reach of patient reported outcome (PRO) assessment completion
時間枠:6 months
The number of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
6 months
Penetration of patient reported outcome (PRO) assessment completion
時間枠:6 months
The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
6 months

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 (推定)

2027年10月1日

一次修了 (推定)

2031年4月1日

研究の完了 (推定)

2031年9月1日

試験登録日

最初に提出

2026年7月20日

QC基準を満たした最初の提出物

2026年7月20日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月29日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

Data to be shared include primary outcomes (completion of Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months), intervention arm, and relevant patient, disease and treatment characteristics (e.g., age, sex, site and stage of cancer, concurrent radiation therapy).

IPD 共有時間枠

Data will be available after study investigators have publicly presented and published key findings, anticipated beginnings from 06/01/2033 for 5 years, until 05/31/2038.

IPD 共有アクセス基準

Data from this study will be available to other researchers upon request to the principal investigator and under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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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

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