A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
2019년 4월 22일 업데이트: Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family.
The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers.
The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment.
The team can make referrals to other specialists.
Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
연구 개요
상세 설명
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
연구 유형
중재적
등록 (실제)
132
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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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Comprehensive Cancer Center
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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
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Patient Inclusion Criteria:
- Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
Patient Exclusion Criteria:
- Patients diagnosed with a hematologic malignancy.
Caregiver Inclusion Criteria:
- Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- Caregivers must be willing to complete surveys at baseline and on monthly basis.
Caregiver Exclusion Criteria:
- Caregivers who are solely professional, paid caregivers
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)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard Supportive Care
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Supportive care for the patient and caregiver will be provided by the treating oncologist.
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실험적: Structured Supportive Care
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Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average total MSAS score
기간: Up to 6 months
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Assessment of patient burden
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Up to 6 months
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Average total FACT-G score
기간: Up to 6 months
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Measure patient quality of life
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Up to 6 months
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Reason for study discontinuation (Patient reported outcome)
기간: Up to 6 months
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Measure of central tendency for why patients discontinued the phase I study.
Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
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Up to 6 months
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Duration on Study
기간: Up to 6 months
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Measure of central tendency of the duration patients were on the phase I study.
Duration on study will serve as the primary objective for sample size determination
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Up to 6 months
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Adverse events
기간: Up to 6 months
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Measure of central tendency of adverse events.
AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities).
The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed.
An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event.
These scores will be compared between study arms
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Up to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean number of hours of palliative care services
기간: Up to 6 months
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Mean number of hours utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
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Type of palliative care services
기간: Up to 6 months
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Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
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Up to 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of adverse events of patients receiving structured and usual supportive care
기간: Up to 6 months
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Up to 6 months
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Average days on study
기간: Up to 6 months
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Up to 6 months
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Change in FACT-G score
기간: From baseline to last contact, up to 6 months
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Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in MSAS score
기간: From baseline to last contact, up to 6 months
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Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in CRA score
기간: From baseline to last contact, up to 6 months
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Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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Change in QOLLTI-F score
기간: From baseline to last contact, up to 6 months
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Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
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From baseline to last contact, up to 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive Cancer Center
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
2015년 10월 25일
기본 완료 (실제)
2019년 1월 10일
연구 완료 (실제)
2019년 1월 10일
연구 등록 날짜
최초 제출
2015년 9월 4일
QC 기준을 충족하는 최초 제출
2015년 9월 4일
처음 게시됨 (추정)
2015년 9월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 22일
마지막으로 확인됨
2019년 4월 1일
추가 정보
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. .