- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675083
Bereaved Parent Conversations on Hope
Bereaved Parent Conversations on Hope (BeHope)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives
Aim 1: To assess feasibility and acceptability of virtual conversations about hope between bereaved parent advisors and learners at St. Jude Children's Research Hospital.
Aim 2: To evaluate impact of discussions about hope on both bereaved parent advisors and learners.
Secondary Objectives
Aim 1: To explore impact of discussion with bereaved parent advisors and subsequent reflection on participant professional identity formation.
This intervention is designed to facilitate direct conversations between learners and bereaved parent advisors about how hope evolves through the child's cancer journey. Providing a structured, virtual opportunity to discuss hope will allow learners to hear about the lived experiences of bereaved parents as they navigated pediatric cancer treatment, end of life, and bereavement. The intervention incorporates a discussion guide to support the conversation and a post-session reflection exercise. Assessments will include quantitative surveys administered pre-intervention and immediately post-intervention, as well as qualitative written reflections from participants and bereaved parents.
Both participant groups will receive an information sheet detailing the study's purpose, procedures, potential risks, and benefits. An affirmative response on the pre-intervention survey to the item, "I would like to participate in a virtual educational discussion about hope," will be considered as implied consent to participate in the educational intervention portion of the study for both participants and facilitators. Investigators plan to enroll a total of 50 learners and 25 bereaved parent advisors.
For each learner who agrees to participate, two bereaved parent advisors will be identified and scheduled to meet virtually with the learner for approximately 1 hour using a virtual platform. Prior to the meeting, bereaved parent advisors will be instructed to select 3 photos that represent how hope evolved during their child's illness journey. Both the learners and bereaved parent advisors will be provided with the discussion guide for review prior to the session. Each virtual meeting will be recorded for implementation fidelity and for reference should any learner or parent concerns arise retrospectively from the conversation.
Immediately following each virtual meeting, both the learners and bereaved parent advisors will be asked to engage in individual short (15 minute) written reflections. Following this, participants will complete additional post-intervention survey questions with data collection managed through an online software platform. A second meeting with the same parents may be held at the learners request and the parents willingness. The participants who agree to and participate in a second meeting will receive open-ended questions and be prompted to complete a timed written reflection after the second meeting.
On an approximately quarterly basis, learners who have previously completed the intervention will be invited to participate in a facilitated group debrief and reflection session. Separately, bereaved parent advisors who have participated in at least one virtual meeting in the preceding quarter will be invited to a discussion and feedback session to share about their experiences with the program. For parents who do not prefer a group meeting, an individual session will be offered. All debriefing sessions will be recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brittany Cowfer, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
Study Locations
-
-
Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Principal Investigator:
- Brittany Cowfer, MD
-
Contact:
- Brittany Cowfer, MD
- Phone Number: 888-226-4343
- Email: referralinfo@stjude.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Intervention Participants must be:
- Students, observers, trainees, and newly hired clinicians,
- ≥18 years old,
- participating in or observing clinical care at St. Jude Children's Research Hospital, and
- willing to participate in the virtual intervention and associated study activities as learners
Intervention Facilitators must be:
- Bereaved parents,
- ≥ 18 years old,
- screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital through Family, Guest and Volunteer Services, and
- willing to participate in the virtual intervention and associated study activities as a facilitator
Exclusion Criteria
Intervention Participants:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Intervention Facilitators:
- Age < 18 years, decline participation, or unable to speak/write in conversational English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Educational Intervention
Intervention Participants: Students, observers, trainees, and newly hired clinicians ≥18 years old participating in or observing clinical care at St. Jude Children's Research Hospital, and willing to participate in the virtual intervention and associated study activities as learners. Intervention Facilitators: Bereaved parents ≥ 18 years old screened and cleared to volunteer as advisers with St. Jude Children's Research Hospital and willing to participate in the virtual intervention and associated study activities as a facilitator. |
See Detailed Description
See Detailed Description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention and Acceptability of Intervention Measures
Time Frame: Day 1 after virtual meeting
|
Feasibility will be evaluated using the Feasibility of Intervention Measure (FIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Acceptability will be evaluated using the Acceptability of Intervention Measure (AIM), which includes four itemized responses that are scored from one to five, such that one represents the lowest possible mean score and five the highest possible mean score.
Feasibility and acceptability will be evaluated for the overall study cohort, including both learners and bereaved parent advisors, and by subgroup.
Feasibility and Acceptability are standardly considered to be achieved with a mean score ≥3 for each.
Higher scores indicate greater perceived feasibility and acceptability.
|
Day 1 after virtual meeting
|
|
Survey
Time Frame: At enrollment and day 1 after virtual meeting
|
To evaluate the impact of discussions about hope on both bereaved parent advisors and learners, investigators will summarize the distribution of responses to the pre and post intervention survey items by reporting frequencies and percentages for each response category.
Pre-intervention surveys will also contain demographic information.
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At enrollment and day 1 after virtual meeting
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Written Reflections
Time Frame: Day 1 after virtual meeting
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Written reflections, captured after each virtual session, will be de-identified and analyzed using content analysis, an inductive approach which may include memo-writing, codebook development, coding, reconciliation, and synthesis to identify patterns and themes that emerge from the reflections.
These will be used to assess impact of the session on both learners and parent advisors.
|
Day 1 after virtual meeting
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Debrief Sessions
Time Frame: Quarterly over 2 years
|
Quarterly debrief sessions will be offered to those who have completed the intervention separately for bereaved parent advisors and learners.
Learner debriefing sessions will be recorded, transcribed, and analyzed qualitatively to assess for impact on professional identity formation.
Optional parent advisor debriefs will also be recorded and analyzed to further assess impact on facilitators.
|
Quarterly over 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brittany Cowfer, MD, St. Jude Children's Research Hospital
Publications and helpful links
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
Keywords
Other Study ID Numbers
- BeHope
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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.
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