Studying Survivorship Care Plans in Head and Neck Cancer
2020년 1월 14일 업데이트: Duke University
Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care
The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics.
Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria.
These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment.
Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences.
The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.
연구 개요
연구 유형
중재적
등록 (실제)
6
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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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Health, Duke 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
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Completed treatment for a head or neck cancer at Duke Cancer Center within 4 months of consent OR
- Will complete treatment for a head and neck cancer at Duke Cancer Center within 3 weeks of consent AND
- Able to read and understand English
- Capable of giving informed consent
- Are at least age 18.
Exclusion Criteria:
- incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: No SCP Control
Patients returning for early follow-up who did not receive SCP.
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간섭 없음: SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
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실험적: eSCP Intervention
Patients currently receiving treatment who will be enrolled to receive an "enhanced" SCP (eSCP) with additional information beyond ASCO guidelines tailored to patient concerns and preferences.
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The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns.
They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Head and Neck Cancer Survivor Knowledge
기간: 5 minutes to complete 3 months after treatment end
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale
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5 minutes to complete 3 months after treatment end
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Change in Head and Neck Cancer Survivor Knowledge
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale in intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distress in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
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5 minutes to complete 3 months after treatment end
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Distress in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses distress through the use of the NCCN Distress Thermometer
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5 minutes to complete 3 months after treatment end
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Change in distress for head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Change in distress for head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Uncertainty in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
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5 minutes to complete 3 months after treatment end
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Change in uncertainty in head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Quality of life in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
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5 minutes to complete 3 months after treatment end
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Change in quality of life in head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Self-efficacy in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete 3 months after treatment end
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Change in self-efficacy in head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Information processing in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete 3 months after treatment end
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Change in information processing in head and neck cancer survivors
기간: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Survivorship care plan perceptions in head and neck cancer survivors
기간: 5 minutes to complete 3 months after treatment end
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Using open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care
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5 minutes to complete 3 months after treatment end
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Survivorship needs after treatment completion -- primary care provider documentation
기간: 10 minutes to complete documentation review of 6 months of PCP records
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Using a documentation checklist developed by the study team, discussions on survivorship needs when returning to clinic will be assessed with a focus on symptom management or incorporation of healthy behaviors to reduce cancer recurrence
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10 minutes to complete documentation review of 6 months of PCP records
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Deborah H Allen, PhD, RN, Duke Health
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)
2017년 4월 19일
기본 완료 (실제)
2020년 1월 2일
연구 완료 (실제)
2020년 1월 2일
연구 등록 날짜
최초 제출
2017년 3월 29일
QC 기준을 충족하는 최초 제출
2017년 4월 4일
처음 게시됨 (실제)
2017년 4월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 14일
마지막으로 확인됨
2020년 1월 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. .
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