Photo-based exploration of hope in young people receiving phase 1/2 cancer therapy

Sharing Hope: A Longitudinal Photo-Narrative Exploration of Hope During Phase 1/2 Clinical Trials For Pediatric Cancer

This project will try to understand how young people (ages 12–25) and their caregivers experience and adapt their hope while they are enrolled in phase 1 or 2 cancer therapy using photos and interviews.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: St. Jude Children's Research Hospital (Academic / other)
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT07444216 on ClinicalTrials.gov

What this trial studies

This is an observational, longitudinal qualitative project that uses participant-generated photo-elicitation interviews and semi-structured interviews with clinicians and caregivers to capture how hope changes over time for young people receiving phase 1/2 cancer therapy. Participants will be guided to select 1–5 photos before each interview to prompt discussion about what they are hoping for, what sustains or challenges hope, and what they want others to understand. Focus groups with patients, caregivers, and clinicians will identify strengths, weaknesses, opportunities, and threats to hope and will be used to co-design a stakeholder-driven supportive intervention. The study does not test an intervention; findings are intended to inform future intervention development.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12–25 with relapsed, refractory, or no-curative-option cancer who are enrolled in or planning to enroll in a phase 1 or phase 2 cancer therapy protocol.

Not a fit: Patients younger than 12, older than 25, not enrolled in phase 1/2 cancer therapy, or those seeking direct therapeutic benefit should not expect medical benefit from participating in this observational project.

Why it matters

Potential benefit: If successful, the findings could inform a stakeholder-designed support program to better sustain hope for patients and families during early-phase cancer therapy.

How similar studies have performed: Photo-narrative and photovoice methods have been used successfully in qualitative oncology and palliative care research, though applying them specifically to pediatric phase 1/2 trial contexts and using findings to co-design an intervention is relatively novel.

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.

Where this trial is running

Memphis, Tennessee

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Alexandra Superdock, MD — St. Jude Children's Research Hospital
• Study coordinator: Alexandra Superdock, MD

Conditions Cancer, Therapy-Related; Photo-elicitation; Patient Participants; Parents/Caregivers; Clinicians; Interviews; Focus Groups