- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03135782
Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy
Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. To determine if training providers on tobacco cessation resources increases the frequency of counseling and referrals at initial and follow-up consultations for cancer patients who use tobacco and are scheduled to receive radiation at Oregon Health and Science University (OHSU).
SECONDARY OBJECTIVES:
I. Increase provider frequency of tobacco use quantification and type. II. Increase frequency of provider assessment of tobacco cessation readiness in current users.
III. Increase frequency and types of tobacco cessation resources and medicines offered and utilized.
IV. Increase frequency and type of follow-up planned if referred to cessation resource.
OUTLINE:
MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.
PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.
PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU Knight Cancer Institute
-
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- MEDICAL CHART REVIEW
- Pre-intervention: 200 patient records between January 1, 2016 and December 31, 2016 are subject to review; the first 50 records with a diagnoses of each cancer type: head and neck, lung, prostate, or breast will be utilized for the review
- Post-intervention: 200 patient records receiving care beginning six months post training are subject to review; the first 50 records with a diagnoses of head and neck, lung, prostate, or breast will be utilized
- PROVIDER TRAINING
- OHSU Radiation Medicine department has agreed to participate as pilot department for this project; all active Radiation Medicine providers are requested to participate in the training; providers have the option to not participate
- TOBACCO CESSATION COACHING
- Patients who are at least 18 years of age
- Speak English
- Report tobacco use within the past 7 days
- Willing to consider quitting smoking
- Patients must be willing to meet four times in person or on the phone to discuss tobacco use
- Patients must be willing to be audio recorded during the sessions
- Patients who meet this criteria will be referred to OHSU Health Promotion Sports Medicine researcher, Carol DeFrancesco, to complete assessment using stages of change tobacco use readiness ruler and question set
- Patient smoking status will be documented in their electronic health record, per routine care
Exclusion Criteria:
Vulnerable Populations
The following groups will be excluded from participation:
- Children
- Decisionally impaired adults
- Prisoners
- Pregnant women
공부 계획
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 (Chart review, training, coaching)
MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training. PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions. PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed. |
보조 연구
Undergo motivational interviewing training
Undergo medical chart review
다른 이름들:
Attend phone or in-person motivational interviewing coaching sessions
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in frequency of tobacco counsel
기간: Baseline up to 24 months
|
Will be compared between the cohort of pre and post intervention.
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
|
Baseline up to 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in frequency and type of follow-up planned if referred to cessation resource assessed by medical chart review
기간: Baseline up to 24 months
|
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
|
Baseline up to 24 months
|
|
Change in frequency and types of tobacco cessation resources and medicines offered and utilized assessed by medical chart review
기간: Baseline up to 24 months
|
Will be tested using a chi-squared test.
If any expected cell count in the contingency table is lower than 5, we will instead use Fisher's exact test.
|
Baseline up to 24 months
|
|
Change in frequency of provider assessment of tobacco cessation readiness in current users assessed by medical chart review
기간: Baseline up to 24 months
|
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
|
Baseline up to 24 months
|
|
Change in provider frequency of tobacco use quantification and type assessed by medical chart review
기간: Baseline up to 24 months
|
Will be summarized using descriptive statistics and compared using chi-square test by tumor type.
Will be tested using Z tests of proportion.
|
Baseline up to 24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: John Holland, OHSU Knight Cancer Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00016428 (기타 식별자: OHSU Knight Cancer Institute)
- NCI-2017-00576 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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