면역 체크포인트 억제제 후보인 흑색종 및 기존 자가면역 질환 환자를 위한 교육 도구 테스트
면역 체크포인트 억제제를 사용한 보조 요법의 후보인 흑색종 및 동반 자가면역 질환 환자를 위한 교육 도구 테스트: 환자 및 제공자에 대한 수용 가능성 및 사용 가능성
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To evaluate the acceptability (e.g., ease of use, design, accessibility, content) of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors.
II. To test the usability in real world-settings of the educational tool (to be developed) and evaluate feasibility of patient recruitment (i.e., ability to identify enough patients and consent at least 50% of the identified patients) in a pilot study.
OUTLINE:
PART A: Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes.
PART B: 2 group of participants will be evaluated sequentially (Participants in group II will be enrolled after all the participants in group I have been assessed).
GROUP I: Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
GROUP II: Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Angeles Lopez-Olivo
- 전화번호: 713-792-9175
- 이메일: amlopezo@mdanderson.org
연구 장소
-
-
Texas
-
Houston, Texas, 미국, 77030
- 모병
- M D Anderson Cancer Center
-
연락하다:
- Maria A. Lopez-Olivo
- 전화번호: 713-792-9175
-
수석 연구원:
- Maria A. Lopez-Olivo
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with melanoma or pre-existing autoimmune disease and clinicians
설명
Inclusion Criteria:
-
Diagnosis of melanoma
-
Diagnosis of pre-existing autoimmune disease
-
Inflammatory bowel disease
- Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist
- For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically
- Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)
-
Rheumatoid arthritis
- Diagnosis of rheumatoid arthritis by a rheumatologist
- Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy
-
Systemic lupus erythematosus
- Diagnosis of systemic lupus erythematosus by a rheumatologist
-
Psoriasis
- Diagnosis of psoriasis by a dermatologist
- Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies
-
Spondyloarthropathies
- Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis/spondylitis by a rheumatologist
- Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy
-
-
Age of 18 years or older
-
Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor
-
E-mail access and computer with Internet access or telephone
-
Ability to communicate in English or Spanish
-
CLINICIAN
-
Prescribed immune checkpoint inhibitors
-
Are providing care for patients with melanoma
-
In the clinics at MD Anderson
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Part A (Interview)
Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content, ease of use, and format of the tool over 45 minutes. |
Participate in interview Navigate educational tool
다른 이름들:
|
|
Part B Group I (standard information)
Patients receive standard educational information during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. |
Complete questionnaire Complete surveys Receive standard educational information
다른 이름들:
|
|
Part B Group II (educational tool)
Patients navigate educational tool over 20 minutes during their clinician encounter. Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter, immediately after the encounter, and at 3 months. |
Complete questionnaire Complete surveys Navigate educational tool
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Decisional conflict scale
기간: Up to 4 years
|
The scale will be used to assess personal perceptions of 1) uncertainty in choosing among options; 2) modifiable factors contributing to uncertainty, such as feeling uninformed, and 3) feeling that the choice is values-based and likely to be implemented. |
Up to 4 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knowledge
기간: Up to 3 months
|
Will be assessed using a questionnaire developed by the research team covering various content areas, including general information about immune checkpoint inhibitors and the associated adverse effects and benefits of the treatments. |
Up to 3 months
|
|
Acceptability
기간: Immediately after the clinical encounter
|
A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures. |
Immediately after the clinical encounter
|
|
Usability
기간: Immediately after the clinical encounter
|
A standard assessment questionnaire will be used to obtain users' ratings of various features of the educational tool, including ease of use, presentation, usefulness and satisfaction. The items in the questionnaire come from the Ottawa Acceptability Measures. |
Immediately after the clinical encounter
|
|
Depression
기간: Up to 3 months
|
Will be assessed using the Depression and Anxiety Stress Scale (DASS). The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia |
Up to 3 months
|
|
Anxiety
기간: Up to 3 months
|
Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. |
Up to 3 months
|
|
Stress
기간: Up to 3 months
|
Will be assessed using the DASS. The DASS is a 21-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. |
Up to 3 months
|
|
CollaboRATE measure
기간: Immediately after the clinical encounter
|
The CollaboRATE questions ask about the effort made to help patients understand their health issues, listen to what matters most to them, and include what matters most to them in choosing what to do next. |
Immediately after the clinical encounter
|
|
Shared decision-making process survey
기간: Immediately after the clinical encounter
|
This instrument measures the extent to which health care providers engage patients in shared decision making. Items are focused on four specific behaviors that are critical for shared decision making -discussion of options, pros, cons and preferences. |
Immediately after the clinical encounter
|
|
Patient's perception of usefulness of the tool
기간: Immediately after the clinical encounter
|
Will use the Preparation for Decision Making Scale (Prep-DM) to assess the patients' perception of how useful the educational tool is in preparing them to communicate with their practitioner at a consultation. It is a 10-item scale developed to evaluate decision processes relating to the preparation of patients for decision making and dialoguing with their practitioners. |
Immediately after the clinical encounter
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Angeles Lopez-Olivo, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 감염 후 장애
- 축성 척추관절염
- 뼈 질환
- 근골격계 질환
- 병리학적 과정
- 부위별 신생물
- 신생물
- 만성 질환
- 질병 속성
- 관절염
- 관절 질환
- 류마티스 질환
- 장 질환
- 결합 조직 질환
- 면역계 질환
- 감염
- 조직학적 유형에 따른 신생물
- 소화기계 질환
- 위장병
- 결장 질환
- 척추 질환
- 척추관절병증
- 강직증
- 피부질환, 구진편평
- 피부병
- 위장염
- 신경외배엽 종양
- 신생물, 생식 세포 및 배아
- 신생물, 신경 조직
- 신경내분비종양
- 모반과 흑색종
- 피부 신생물
- 척추관절염
- 척추염
- 대장염
- 관절염, 전염성
- 병리학적 상태, 징후 및 증상
- 피부 및 결합 조직 질환
- 전신성 홍반성 루푸스
- 척추염, 강직
- 대장염, 궤양성
- 건선
- 흑색종
- 크론병
- 자가면역질환
- 관절염, 류마티스
- 관절염, 건선
- 염증성 장 질환
- 관절염, 반응성
- 보건 서비스 관리
- 건강 관리 품질, 접근 및 평가
- 조사 기술
- 역학적 방법
- 데이터 수집
- 건강 관리 평가 메커니즘
- 건강 관리의 질
- 공중 위생
- 환경 및 공중 보건
- 품질 지표, 건강 관리
- 건강 서비스
- 의료 시설 인력 및 서비스
- 아동 건강 서비스
- 지역 사회 보건 서비스
- 예방 보건 서비스
- 사회 경제적 요인
- 인구 특성
- 주제로 지침
- 품질 보증, 건강 관리
- 행동 양식
- 주제로 인터뷰
- 치료의 표준
- 조기 개입, 교육
- 교육 상태
- 주제로 지침을 연습하십시오
기타 연구 ID 번호
기타 연구 ID 번호
- 2020-0843
- 2020-0843 (기타 식별자: M D Anderson Cancer Center)
- NCI-2021-00565 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- K08CA237619 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .