Pediatric OncologyACCOMPANINCT07921589
Pilot Testing ACCOMPANI: A Nurse-Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology
A study testing ACCOMPANI Intervention in people with Pediatric Oncology and Childhood Cancers, run by Dana-Farber Cancer Institute.
Trial summary
This study is evaluating ACCOMPANI, a nurse-targeted intervention intended to promote psychosocial equity in pediatric oncology nurses and stakeholders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Oncology, Childhood Cancers, Psychosocial Circumstances
- What is being tested?
- ACCOMPANI Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2027to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nurses will be excluded if they are:
- In orientation OR
- no longer working as a bedside pediatric oncology nurse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- ACCOMPANI Intervention, Usual Care
- Keywords
- Pediatric Oncology, Childhood Cancer, Psychosocial Inequity, Nurse interventions
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCOMPANI InterventionBehavioural
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.
Usual CareBehavioural
Participants in the comparator group are assigned to usual care.
| Study group | Role | What they receive |
|---|---|---|
| ACCOMPANI Intervention | Experimental | 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. Receives: Behavioral: ACCOMPANI Intervention |
| Usual Care | Active comparator | Participants in the comparator group are assigned to usual care. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial.
Measured: 6 months
Intervention completion rate
Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment.
Measured: Up to 5 weeks
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.
Measured: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
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.
Measured: At post-intervention follow-up (T2), approximately 5 weeks after baseline.
Secondary outcomes (6)
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.
Measured: 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
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.
Measured: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
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.
Measured: Weekly up to 4 weeks
Number of Components Accessed
The number of components accessed is counted for each week and summed across all 4 sessions.
Measured: Weekly up to 4 weeks
Number of Modules Completed
The number of modules completed is counted for each week and summed across all 4 sessions.
Measured: Weekly up to 4 weeks
Number of Access Attempts
The number of access attempts is counted for each week and summed across all 4 sessions.
Measured: Weekly up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start27 Apr 2027 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric OncologyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment, with intervention and usual care groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Ijeoma Julie Eche-Ugwu, MD, Dana-Farber Cancer Institute
- Investigators
- Ijeoma Eche-Ugwu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921589
- Sponsor's protocol ID
- 26-474
- Acronym
- ACCOMPANI
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing ACCOMPANI: A Nurse?Targeted Intervention to Promote Psychosocial Equity in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT07921589
- Acronym / sponsor ID
- ACCOMPANI / 26-474
- Keywords
- Pediatric Oncology, Childhood Cancer, Psychosocial Inequity, Nurse interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 27 Apr 2027 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating ACCOMPANI, a nurse-targeted intervention intended to promote psychosocial equity in pediatric oncology nurses and stakeholders.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, with intervention and usual care groups
| Arm | Type | Receives |
|---|---|---|
| ACCOMPANI Intervention | Experimental | Behavioral: ACCOMPANI InterventionNurse 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. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants in the comparator group are assigned to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Nurses will be excluded if they are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCOMPANI InterventionNurse 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. | Behavioural | ACCOMPANI Intervention |
| Usual CareParticipants in the comparator group are assigned to usual care. | Behavioural | Usual Care |
Primary outcome
Enrollment Rate
Time frame: 6 months
Enrollment rate is defined as the proportion of approached nurses who enroll in the pilot randomized controlled trial.
Intervention completion rate
Time frame: Up to 5 weeks
Completion will be defined as the proportion of enrolled participants who complete the post-intervention follow-up survey assessment.
Acceptability of Intervention (AIM) Rate
Time frame: 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.
Appropriateness of Intervention (IAM) Rate
Time frame: 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.
6 secondary outcomes
Change in New General Self-Efficacy Scale (NGSE) score from Baseline to Post-Intervention Follow-Up
Time frame: 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
Time frame: At baseline and post-intervention follow-up (T2), up to approximately 5 weeks
Duration of Contact with Components of the Intervention
Time frame: Weekly up to 4 weeks
Number of Components Accessed
Time frame: Weekly up to 4 weeks
Number of Modules Completed
Time frame: Weekly up to 4 weeks
Number of Access Attempts
Time frame: Weekly up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ijeoma Eche-Ugwu, MD principal investigator
Dana-Farber Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing ACCOMPANI Intervention in people with Pediatric Oncology and Childhood Cancers, run by Dana-Farber Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ijeoma Eche-Ugwu, MD (857-215-1248, ijeomaj_eche@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.