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Symptom Management to Improve Completion of Patient-reported Outcome Measures

2026년 7월 28일 업데이트: 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.

연구 개요

상세 설명

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).

연구 유형

중재적

등록 (추정된)

78

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Eric Adjei Boakye, PhD
  • 전화번호: 313-874-6218
  • 이메일: eadjei1@hfhs.org

연구 장소

    • Michigan
      • Detroit, Michigan, 미국, 48202
        • Henry Ford Health
        • 연락하다:
          • Eric Adjei Boakye, PhD
          • 전화번호: (313) 874-6218
          • 이메일: eadjei1@hfhs.org

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reach of patient reported outcome (PRO) assessment completion
기간: 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
기간: 6 months
The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 10월 1일

기본 완료 (추정된)

2031년 4월 1일

연구 완료 (추정된)

2031년 9월 1일

연구 등록 날짜

최초 제출

2026년 7월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 20일

처음 게시됨 (실제)

2026년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 28일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다