NCT07444216 A Longitudinal Photo-Narrative Exploration of Hope During Phase 1/2 Clinical Trials For Pediatric Cancer
| NCT ID | NCT07444216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Cancer, Therapy-Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-09 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-04-09 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find better ways to help support families in their hopes during cancer treatment. Primary Objective * To characterize themes related to how patients and parents/caregivers narrate their experience of 'hope' when receiving cancer therapy on a phase 1/2 clinical trial, with a focus on whether, why, when, and how patients' and caregivers' hopes adapt to changing circumstances. * To engage patients, caregivers, and clinicians in focus groups to identify strengths, weaknesses, opportunities, and threats to hope during phase 1/2 clinical trial participation and facilitate the co-design of a stakeholder-driven supportive intervention related to hope based on focus group recommendations. Secondary Objective * To describe health care provider perspectives on patient and family hope and goal-care concordance in the context of phase 1/2 clinical trials.
Eligibility Criteria
Inclusion Criteria: Patient participants must * Be 12 to 25 years of age. AND * Have a primary cancer diagnosis that is relapsed, refractory, or without curative standard-of-care options as follows: * 'Relapsed' disease is defined as disease recurrence following a prior complete or partial response to initial therapy. * 'Refractory' disease is defined as failure to achieve remission or response with standard upfront therapy. * Diagnoses will be considered 'without curative standard of care options' if there is no evidence-based curative treatment regimen or where standard therapies offer only palliative or non-curative intent (based on the assessment of the primary attending or division tumor board). AND * Be enrolled OR planning to enroll in a phase 1 or phase 2 trial for cancer-directed therapy.\* Patients will remain eligible until 4 weeks after they begin trial therapy, after which they are no longer eligible unless they subsequently enroll on a different clinical trial. Caregiver participants must * Be a parent or primary caregiver to a child of any age who * Has a primary cancer diagnosis that is relapsed, refractory, or without curative standard-of-care options AND * Is enrolled OR planning to enroll on a phase 1 or phase 2 trial for cancer-directed therapy.\* Parents will remain eligible until 4 weeks after their child begins trial therapy, after which they are no longer eligible unless their child subsequently enrolls on a different clinical trial. * Be ≥ 18 years of age or legally emancipated Medical clinician participants (Primary Objectives 1-2) must * Be a physician, advanced practice provider, or nurse providing direct patient care to the patient participant and/or to the child of the caregiver participant. Psychosocial clinician participants (Primary Objective 2 only) must * Be a psychosocial clinician (e.g., social worker, psychologist, chaplain, child life specialist, music therapist, cultural navigator, etc.) AND * Provide direct or consultative care to pediatric or adolescent/young adult patients with relapsed, refractory, or high-risk cancer and/or their families. Exclusion Criteria: Patients, Caregivers, and Clinicians will be excluded if they: * Do not meet inclusion criteria. * Decline, refuse, or are unwilling to participate. * Are a minor without a legal guardian available or willing to provide informed consent. * Lack the cognitive, communicative, or physical capacity to meaningfully participate in a photo-narrative interview, as determined by the research team in consultation with the patient, caregiver, and primary oncology team. This includes, but is not limited to, individuals with profound neurocognitive impairment, non-responsiveness, or other conditions that preclude the ability to engage in basic reflection, expression, or shared conversation about images.
Contact & Investigator
Alexandra Superdock, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07444216 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cancer, Therapy-Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07444216 currently recruiting?
Yes, NCT07444216 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07444216 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07444216 clinical trial?
NCT07444216 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Alexandra Superdock, MD at St. Jude Children's Research Hospital. The trial plans to enroll 100 participants.
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