- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04602910
Developing a Web-based Shared Decision-making Tool for Fertility Preservation
Developing a Web-based Shared Decision-making Tool for Fertility Preservation Among Reproductive-age Women With Breast Cancer: An Action Research Approach
연구 개요
상세 설명
Background: The pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive- age patients with breast cancer have safe options when choosing the type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed.
Objective: The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.
Methods: We used the action research cycle of observing, reflecting, planning, and acting to develop a web-based SDM tool. The following four phrases were applied: (1) Observe and reflect: Collect and analyze the decision-making experiences of patients and health care providers; (2) Reflect and plan: Apply the initial results to create a paper design and modify the content; (3) Plan and act: Brainstorm about the web pages, and modify the content; (4) Act and observe: Evaluate the effectiveness, and refine the website SDM. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. The effectiveness was evaluated using the Preparation for Decision-Making (prepDM) scale.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Health provider who ever cared the patients with breast cancer.
- Patients with breast cancer who are younger than 50 years old.
Exclusion Criteria:
- none
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: the phases of planning and acting
Each part of the website page was assessed for comprehensibility and usability by patients.
Health care providers were asked to assess the acceptability of the website.
A 5-point Likert scale was used for patient and health care provider ratings for each item.
If the score were less than 3, then we would modify the website content based on the user feedback from patients and health care providers
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Five major parts were developed with the use of the action research approach.
The Introduction and Options (parts 1 and 2) describe the severity of the cancer treatment and infertility and the knowledge of fertility preservation, respectively.
The SDM tool was designed as a step by step process (part 3) that involves the comparison of options, patient's values and preferences, their knowledge regarding infertility and options, and reaching a collective decision.
The Resources (part 4) provide information on the hospitals that provide such services, and the References (part 5) list all the literature cited in the website.
The results show the web-based SDM meets both the patients' and health providers' needs and helps reproductive-age patients with breast cancer make decisions on fertility preservation.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preparation for Decision-Making
기간: 1 week
|
We evaluated the effectiveness of the Preparation for Decision-Making (prepDM) scale.
Both patients and health care providers were invited to answer 10 questions by responding with a 5-point Likert scale rating (from 1 to 5).
A higher score indicated greater agree with the effect.
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1 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sheng-Miauh Huang, PhD, Department of Nursing
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 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. .