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Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology (ACCOMPANI)

2 november 2026 bijgewerkt door: Ijeoma Julie Eche-Ugwu, MD, Dana-Farber Cancer Institute

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: Usual Care

Participants in the comparator group are assigned to usual care.
Gedragsmatig: Usual Care

Participants in the comparator group are assigned to usual care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Enrollment Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dana-Farber Cancer Institute

Medewerkers

American Cancer Society, Inc.

Onderzoekers

  • Hoofdonderzoeker: Ijeoma Eche-Ugwu, MD, Dana-Farber Cancer Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

27 april 2027

Primaire voltooiing (Geschat)

30 september 2028

Studie voltooiing (Geschat)

30 december 2028

Studieregistratiedata

Eerst ingediend

2 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-474

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Data can be shared no earlier than 1 year following the date of publication

IPD-toegangscriteria voor delen

Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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