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Not yet recruitingNCT07921589ACCOMPANIUpdated Nov 6, 2026

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

An interventional study of ACCOMPANI Intervention and Usual Care in Pediatric Oncology, Childhood Cancers and Psychosocial Circumstances, sponsored by Dana-Farber Cancer Institute. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study is evaluating ACCOMPANI, a nurse-targeted intervention intended to promote psychosocial equity in pediatric oncology nurses and stakeholders.

Read the detailed description

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.

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Conditions studied

  • Pediatric Oncology
  • Childhood Cancers
  • Psychosocial Circumstances

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Keywords

  • Pediatric Oncology
  • Childhood Cancer
  • Psychosocial Inequity
  • Nurse interventions
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In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

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Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Nurses will be excluded if they are:

    • In orientation OR
    • no longer working as a bedside pediatric oncology nurse
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: ACCOMPANI Intervention

  • Active comparator
    Usual Care

    Participants in the comparator group are assigned to usual care.

    Behavioral: Usual Care

Interventions

  • BehavioralACCOMPANI 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.

  • BehavioralUsual Care

    Participants in the comparator group are assigned to usual care.

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What researchers measure

Primary outcomes

  1. Enrollment Rate

    Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial.

    Time frame: 6 months

  2. Intervention completion rate

    Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment.

    Time frame: Up to 5 weeks

  3. Acceptability of Intervention (AIM) Rate

    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.

    Time frame: At post-intervention follow-up (T2), approximately 5 weeks after baseline.

  4. Appropriateness of Intervention (IAM) Rate

    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.

    Time frame: At post-intervention follow-up (T2), approximately 5 weeks after baseline.

Secondary outcomes

  1. Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up

    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.

    Time frame: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks

  2. Change in Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals-Revised (IAPCC-R) score from Baseline to Post-Intervention Follow-Up

    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.

    Time frame: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks

  3. Duration of Contact with Components of the Intervention

    The duration of contact with components of the intervention is measured in minutes for each week and summed across all 4 sessions.

    Time frame: Weekly up to 4 weeks

  4. Number of Components Accessed

    The number of components accessed is counted for each week and summed across all 4 sessions.

    Time frame: Weekly up to 4 weeks

  5. Number of Modules Completed

    The number of modules completed is counted for each week and summed across all 4 sessions.

    Time frame: Weekly up to 4 weeks

  6. Number of Access Attempts

    The number of access attempts is counted for each week and summed across all 4 sessions.

    Time frame: Weekly up to 4 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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

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

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07921589
Collaborators
American Cancer Society, Inc.
Responsible party
Ijeoma Julie Eche-Ugwu, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Nov 6, 2026
Start date
Apr 27, 2027 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Ijeoma Eche-Ugwu, MD
Contact
ijeomaj_eche@dfci.harvard.edu
857-215-1248
Ijeoma Eche-Ugwu, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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