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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Ijeoma Eche-Ugwu, MD
- Telefonní číslo: 857-215-1248
- E-mail: ijeomaj_eche@dfci.harvard.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: Usual Care
Participants in the comparator group are assigned to usual care. |
Participants in the comparator group are assigned to usual care. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Enrollment Rate
Časové okno: 6 months
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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
Časové okno: Up to 5 weeks
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Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment. |
Up to 5 weeks
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Acceptability of Intervention (AIM) Rate
Časové okno: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
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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.
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Appropriateness of Intervention (IAM) Rate
Časové okno: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
Časové okno: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
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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
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Change in Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals-Revised (IAPCC-R) score from Baseline to Post-Intervention Follow-Up
Časové okno: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
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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
Časové okno: Weekly up to 4 weeks
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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
Časové okno: Weekly up to 4 weeks
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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
Časové okno: Weekly up to 4 weeks
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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
Časové okno: Weekly up to 4 weeks
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The number of access attempts is counted for each week and summed across all 4 sessions. |
Weekly up to 4 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Ijeoma Eche-Ugwu, MD, Dana-Farber Cancer Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 26-474
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
Data can be shared no earlier than 1 year following the date of publication
Kritéria přístupu pro sdílení IPD
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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Studuje lékový produkt regulovaný americkým FDA
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