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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ijeoma Eche-Ugwu, MD
- Phone Number: 857-215-1248
- Email: ijeomaj_eche@dfci.harvard.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
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. |
|
Active Comparator: Usual Care
Participants in the comparator group are assigned to usual care. |
Participants in the comparator group are assigned to usual care. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment Rate
Time Frame: 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
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. |
Up to 5 weeks
|
|
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. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
|
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. |
At post-intervention follow-up (T2), approximately 5 weeks after baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ijeoma Eche-Ugwu, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.