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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Ijeoma Eche-Ugwu, MD
- Telefonszám: 857-215-1248
- E-mail: ijeomaj_eche@dfci.harvard.edu
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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. |
|
Aktív összehasonlító: Usual Care
Participants in the comparator group are assigned to usual care. |
Participants in the comparator group are assigned to usual care. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Enrollment Rate
Időkeret: 6 months
|
Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial. |
6 months
|
|
Intervention completion rate
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
Időkeret: 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
Időkeret: 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
|
|
Duration of Contact with Components of the Intervention
Időkeret: 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
|
|
Number of Components Accessed
Időkeret: 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
|
|
Number of Modules Completed
Időkeret: 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
|
|
Number of Access Attempts
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Ijeoma Eche-Ugwu, MD, Dana-Farber Cancer Institute
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 26-474
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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 megosztási időkeret
Data can be shared no earlier than 1 year following the date of publication
IPD-megosztási hozzáférési feltételek
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .