이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

암 환자의 약물 안전성 및 우려 사항 추적을 위한 자가 모니터링 플랫폼

2026년 11월 5일 업데이트: University of Michigan Rogel Cancer Center

자가 투약 안전성 이벤트 추적을 위한 기술 활용에서의 환자 참여

This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

71

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Comprehensive Cancer Center

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Participants are adult patients (aged 18 years or older)
  • Diagnosed with lung, colorectal, breast, or prostate cancer
  • Are currently receiving active cancer treatments
  • Are self-managing one or more prescribed cancer medications
  • Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
  • Speaks and reads English or has a support person (family member or friend) who can assist

Exclusion Criteria:

  • Can't access technology or do not use technology
  • Do not have access to the internet
  • Do not speak or read English
  • Not permitted to participate by their health care providers

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Health services research (self-monitoring platform)

Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired.
다른: Survey Administration

Ancillary studies

다른: Electronic Health Record Review

Ancillary studies

다른: Interview

Ancillary studies

다른: Educational Intervention

Receive educational materials and resources

다른 이름들:
  • 중재 교육
  • 교육에 의한 개입
  • 교육을 통한 개입
  • 개입, 교육
절차: Follow-Up

Receive follow-up contact

다른 이름들:
  • 적극적인 후속 조치
  • 임상 징후 후속 조치
  • CLSFUP
  • 후속 조치
  • 팔로우업
  • 팔로우
다른: Internet-Based Intervention

Use self-monitoring platform

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Self-reported system usability
기간: Up to 6 months

Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Perceived usefulness
기간: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Ease of use
기간: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Attitudes toward use
기간: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Intention to use and continuous use of the system over time
기간: Up to 12 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 12 months
Self-reported patient engagement
기간: Up to 6 months

Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.
Up to 6 months
System usage over time
기간: Up to 12 months

Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
Patient activation levels
기간: Up to 6 months

Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Medication self-management ability
기간: Up to 6 months

Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Symptom distress
기간: Up to 6 months

Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Health related quality of life
기간: Up to 6 months

Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Number of emergency room visits
기간: Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
Number of hospitalizations
기간: Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
User experiences with the system
기간: Up to 6 months

Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Self-tracked, structured medication safety events or concerns
기간: Up to 12 months

To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume.
Up to 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Michigan Rogel Cancer Center

협력자

Agency for Healthcare Research and Quality (AHRQ)

수사관

  • 수석 연구원: Yun Jiang, University of Michigan Rogel Cancer Center
  • 수석 연구원: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics

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 (실제)

2026년 1월 9일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2025년 12월 4일

QC 기준을 충족하는 최초 제출

2025년 12월 4일

처음 게시됨 (실제)

2025년 12월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UMCC 2025.050
  • NCI-2025-08754 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • HUM00272763 (기타 식별자: University of Michigan)
  • R01HS027846 (미국 AHRQ 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

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