- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07723495
Symptom Management to Improve Completion of Patient-reported Outcome Measures
Promoting Patient Reporting of Outcome Measures Through Technology Integrated Self-management and Engagement (PROMISE)
연구 개요
상태
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:
- 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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Eric Adjei Boakye, PhD
- 전화번호: 313-874-6218
- 이메일: eadjei1@hfhs.org
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Health
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연락하다:
- Eric Adjei Boakye, PhD
- 전화번호: (313) 874-6218
- 이메일: eadjei1@hfhs.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
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
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.
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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.
|
|
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reach of patient reported outcome (PRO) assessment completion
기간: 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
기간: 6 months
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The percent of completed Patient-Reported Outcomes Measurement Information System (PROMIS) assessments over 6 months.
|
6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 19934
- K01CA308852-01A1 (기타 식별자: NCI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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