Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology (ACCOMPANI)
Pilot Testing ACCOMPANI: A Nurse?Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology
This study is evaluating ACCOMPANI, a nurse-targeted intervention intended to promote psychosocial equity in pediatric oncology nurses and stakeholders.
研究概览
详细说明
This protocol, titled "Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology," includes multiple study aims. For qualitative aims, participants will be recruited from the relevant pediatric oncology nurse population, and activities may include focus groups, stakeholder sessions, and semi-structured interviews conducted remotely or in approved private settings.
For the pilot intervention aim, nurse participants will attend four study visits, with sessions planned at approximately 30 minutes weekly. Participants will be randomized in waves until the target of 20 participants per group is reached for the intervention and usual care groups. Each intervention group will include 5 to 10 participants, and sessions will be offered on a rolling basis approximately 1 to 2 weeks apart depending on enrollment and study team availability.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ijeoma Eche-Ugwu, MD
- 电话号码：857-215-1248
- 邮箱：ijeomaj_eche@dfci.harvard.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pediatric oncology nurses who work at Dana-Farber Cancer Institute or Boston Children's Hospital in a:
- Full time OR Part time
- Provide direct care to children with cancer and their families
- Inpatient OR outpatient setting
- Age 18 years and older
Exclusion Criteria:
-
Nurses will be excluded if they are:
- In orientation OR
- no longer working as a bedside pediatric oncology nurse
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ACCOMPANI Intervention
Nurse participants receive the ACCOMPANI intervention through four study visits. Sessions are planned to be about 30 minutes weekly, delivered in groups of 5-10 participants, with rolling scheduling based on enrollment and staff availability. Sessions occur in private areas within the DFCI/BCH campus. Participants are reminded of consent elements at the beginning of each session. |
Nurse participants receive the ACCOMPANI intervention through four study visits. Sessions are planned to be about 30 minutes weekly, delivered in groups of 5-10 participants, with rolling scheduling based on enrollment and staff availability. Sessions occur in private areas within the DFCI/BCH campus. Participants are reminded of consent elements at the beginning of each session. |
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有源比较器：Usual Care
Participants in the comparator group are assigned to usual care. |
Participants in the comparator group are assigned to usual care. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Enrollment Rate
大体时间：6 months
|
Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial. |
6 months
|
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Intervention completion rate
大体时间：Up to 5 weeks
|
Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment. |
Up to 5 weeks
|
|
Acceptability of Intervention (AIM) Rate
大体时间：At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
The AIM assessment has 4 items scored on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). A higher score is greater perceived acceptability. An overall score for each participant is calculated as the mean of the responses to the 4 items. The AIM rate is the proportion of particpants who have an overall mean score of 4 or higher. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
|
Appropriateness of Intervention (IAM) Rate
大体时间：At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
The IAM assessment has 4 items scored on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). A higher score is greater perceived appropriateness. An overall score for each participant is calculated as the mean of the responses to the 4 items. The IAM rate is the proportion of particpants who have an overall mean score of 4 or higher. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
大体时间：At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
The NGSE assessment has 8 items scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). A higher score is greater self-efficacy. An overall score for each participant is calculated as the mean of the responses to the 8 items. The change in NGSE score is the NGSE score at post-intervention follow-up less the NGSE score at baseline. |
At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
|
Change in Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals-Revised (IAPCC-R) score from Baseline to Post-Intervention Follow-Up
大体时间：At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
The IAPCC-R assessment has 25 items scored on a 4-point scale (1 = strongly agree to 4 = strongly disagree). A higher score is greater self-efficacy. An overall score for each participant is calculated with a range of 25-100. The change in IAPCC-R score is the IAPCC-R score at post-intervention follow-up less the IAPCC-R score at baseline. |
At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
|
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Duration of Contact with Components of the Intervention
大体时间：Weekly up to 4 weeks
|
The duration of contact with components of the intervention is measured in minutes for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
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Number of Components Accessed
大体时间：Weekly up to 4 weeks
|
The number of components accessed is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
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Number of Modules Completed
大体时间：Weekly up to 4 weeks
|
The number of modules completed is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
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Number of Access Attempts
大体时间：Weekly up to 4 weeks
|
The number of access attempts is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
|
合作者和调查者
调查人员
- 首席研究员：Ijeoma Eche-Ugwu, MD、Dana-Farber Cancer Institute
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD 共享时间框架
Data can be shared no earlier than 1 year following the date of publication
IPD 共享访问标准
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
IPD 共享支持信息类型
- 研究方案
- 树液
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