Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
2017년 2월 28일 업데이트: Kathleen Mooney, University of Utah
Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.
For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms.
The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment.
The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner.
On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns.
The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms.
The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness & tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue.
Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group.
Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.
연구 유형
연구 유형
중재적
등록 (실제)
등록
358
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt-Ingram Cancer Center
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah Huntsman Cancer Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult (age 18 or over)
- Have a histological diagnosis of cancer
- a life expectancy of at least 3 months and cognitively able to participate
- Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
- care is under the direction of one of the 8 designated provider teams;
- English speaking;
- has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.
Exclusion Criteria:
- patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
- patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
- Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.
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: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: Usual Care
Patients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms.
The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions.
Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner.
Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.
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실험적: Symptom Alert and Coaching
Patients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines. |
Patients heard self-care messages when they reported a symptom was present.
The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily.
The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient reported symptom levels
기간: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
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Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medical Encounters Telephone Interview
기간: Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
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Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization.
If they reported they did have a medical encounter, the research staff would call and conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored.
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Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
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Patient reported symptom related interference with daily activities
기간: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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This is a one item question asked daily during the symptom monitoring call about the level of interference their symptoms had on their daily activities (0-10 scale).
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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SF-36 Functional Status
기간: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Functional status was measured monthly using the SF-36.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work interference
기간: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work Limitations Questionnaire
기간: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient End of Study Telephone Interview
기간: Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
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An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
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Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
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Evaluation of automated and other self care strategies used and their effectiveness
기간: Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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The symptom monitoring system tracked when an intervention participant heard a self care strategy during the course of the week.
Each week patients would report on how helpful (1-10 scale) the automated self care measures were for the specific symptoms.
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Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Kathleen H Mooney, PhD, University of Utah
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 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
연구 시작
2007년 9월 1일
기본 완료 (실제)
기본 완료
2012년 4월 1일
연구 완료 (실제)
연구 완료
2012년 4월 1일
연구 등록 날짜
최초 제출
최초 제출
2013년 10월 22일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2013년 10월 25일
처음 게시됨 (추정)
처음 게시됨
2013년 11월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2017년 3월 1일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 28일
마지막으로 확인됨
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 17472
- 5R01CA120558 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .