- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07675083
Bereaved Parent Conversations on Hope
Bereaved Parent Conversations on Hope (BeHope)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Primary Objectives
Aim 1: To assess feasibility and acceptability of virtual conversations about hope between bereaved parent advisors and learners at St. Jude Children's Research Hospital.
Aim 2: To evaluate impact of discussions about hope on both bereaved parent advisors and learners.
Secondary Objectives
Aim 1: To explore impact of discussion with bereaved parent advisors and subsequent reflection on participant professional identity formation.
This intervention is designed to facilitate direct conversations between learners and bereaved parent advisors about how hope evolves through the child's cancer journey. Providing a structured, virtual opportunity to discuss hope will allow learners to hear about the lived experiences of bereaved parents as they navigated pediatric cancer treatment, end of life, and bereavement. The intervention incorporates a discussion guide to support the conversation and a post-session reflection exercise. Assessments will include quantitative surveys administered pre-intervention and immediately post-intervention, as well as qualitative written reflections from participants and bereaved parents.
Both participant groups will receive an information sheet detailing the study's purpose, procedures, potential risks, and benefits. An affirmative response on the pre-intervention survey to the item, "I would like to participate in a virtual educational discussion about hope," will be considered as implied consent to participate in the educational intervention portion of the study for both participants and facilitators. Investigators plan to enroll a total of 50 learners and 25 bereaved parent advisors.
For each learner who agrees to participate, two bereaved parent advisors will be identified and scheduled to meet virtually with the learner for approximately 1 hour using a virtual platform. Prior to the meeting, bereaved parent advisors will be instructed to select 3 photos that represent how hope evolved during their child's illness journey. Both the learners and bereaved parent advisors will be provided with the discussion guide for review prior to the session. Each virtual meeting will be recorded for implementation fidelity and for reference should any learner or parent concerns arise retrospectively from the conversation.
Immediately following each virtual meeting, both the learners and bereaved parent advisors will be asked to engage in individual short (15 minute) written reflections. Following this, participants will complete additional post-intervention survey questions with data collection managed through an online software platform. A second meeting with the same parents may be held at the learners request and the parents willingness. The participants who agree to and participate in a second meeting will receive open-ended questions and be prompted to complete a timed written reflection after the second meeting.
On an approximately quarterly basis, learners who have previously completed the intervention will be invited to participate in a facilitated group debrief and reflection session. Separately, bereaved parent advisors who have participated in at least one virtual meeting in the preceding quarter will be invited to a discussion and feedback session to share about their experiences with the program. For parents who do not prefer a group meeting, an individual session will be offered. All debriefing sessions will be recorded.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Brittany Cowfer, MD
- Номер телефона: 888-226-4343
- Электронная почта: referralinfo@stjude.org
Места учебы
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Tennessee
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Memphis, Tennessee, Соединенные Штаты, 38105
- St. Jude Children's Research Hospital
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Главный следователь:
- Brittany Cowfer, MD
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Контакт:
- Brittany Cowfer, MD
- Номер телефона: 888-226-4343
- Электронная почта: referralinfo@stjude.org
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria
Intervention Participants must be:
- Students, observers, trainees, and newly hired clinicians,
- ≥18 years old,
- participating in or observing clinical care at St. Jude Children's Research Hospital, and
- willing to participate in the virtual intervention and associated study activities as learners
Intervention Facilitators must be:
- Bereaved parents,
- ≥ 18 years old,
- screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital through Family, Guest and Volunteer Services, and
- willing to participate in the virtual intervention and associated study activities as a facilitator
Exclusion Criteria
Intervention Participants:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Intervention Facilitators:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Educational Intervention
Intervention Participants: Students, observers, trainees, and newly hired clinicians ≥18 years old participating in or observing clinical care at St. Jude Children's Research Hospital, and willing to participate in the virtual intervention and associated study activities as learners. Intervention Facilitators: Bereaved parents ≥ 18 years old screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital and willing to participate in the virtual intervention and associated study activities as a facilitator. |
See Detailed Description
See Detailed Description
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility of Intervention and Acceptability of Intervention Measures
Временное ограничение: Day 1 after virtual meeting
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Feasibility will be evaluated using the Feasibility of Intervention Measure (FIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Acceptability will be evaluated using the Acceptability of Intervention Measure (AIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Feasibility and acceptability will be evaluated for the overall study cohort, including both learners and bereaved parent advisors, and by subgroup.
Feasibility and Acceptability are standardly considered to be achieved with a mean score ≥3 for each.
Higher scores indicate greater perceived feasibility and acceptability.
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Day 1 after virtual meeting
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Survey
Временное ограничение: At enrollment and day 1 after virtual meeting
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To evaluate the impact of discussions about hope on both bereaved parent advisors and learners, investigators will summarize the distribution of responses to the pre and post intervention survey items by reporting frequencies and percentages for each response category.
Pre-intervention surveys will also contain demographic information.
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At enrollment and day 1 after virtual meeting
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Written Reflections
Временное ограничение: Day 1 after virtual meeting
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Written reflections, captured after each virtual session, will be de-identified and analyzed using content analysis, an inductive approach which may include memo-writing, codebook development, coding, reconciliation, and synthesis to identify patterns and themes that emerge from the reflections.
These will be used to assess impact of the session on both learners and parent advisors.
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Day 1 after virtual meeting
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Debrief Sessions
Временное ограничение: Quarterly over 2 years
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Quarterly debrief sessions will be offered to those who have completed the intervention separately for bereaved parent advisors and learners.
Learner debriefing sessions will be recorded, transcribed, and analyzed qualitatively to assess for impact on professional identity formation.
Optional parent advisor debriefs will also be recorded and analyzed to further assess impact on facilitators.
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Quarterly over 2 years
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Соавторы и исследователи
Следователи
- Главный следователь: Brittany Cowfer, MD, St. Jude Children's Research Hospital
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- BeHope
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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