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

NCT07444216 | Recruiting

• 3 other identifiers: SHAREHOPE5K12CA270369NCI-2026-01388
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Therapy-Related

Keywords

Photo-elicitation; Patient Participants; Parents/Caregivers; Clinicians; Interviews; Focus Groups

Outcome Measures

Primary Outcomes (4)

• Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview

  Semi-structured photo-narrative interviews with patients and caregivers will include the use of longitudinal photo-elicitation methods and participant engagement in photo-narrative experiences. Clinician interviews and electronic medical record data will be triangulated to enhance our understanding of the clinical context. Interview transcripts will undergo reflexive thematic analysis to generate key themes specific to participant perspectives and experiences around hope in the setting of phase 1/2 pediatric cancer clinical trials. Interviews will be audio-recorded, professionally transcribed, and de-identified prior to analysis. Transcripts and associated metadata will be imported into a secure, password-protected qualitative data management software platform to facilitate mixed-methods analysis. Participants will be invited, but not required, to share the digital photograph files used during their interview via secure institutional email or encrypted file transfer.

  At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)

• Demographic survey

  Demographic characteristics will be monitored for purposeful sampling, with the goal of reflecting the demographic characteristics of the institution and surrounding region. Collected characteristics include patient age, patient/caregiver gender, patient/caregiver race, patient/caregiver ethnicity, and patient/caregiver religious affiliation.

  At enrollment

• Electronic medical record (EMR) Review

  EMR data will be used for triangulation of semi-structured photo-narrative interviews with patients and caregivers to enhance our understanding of the clinical context. Clinical factors including disease status, treatment, complications, symptoms, medical interventions/procedures, consultant involvement, unplanned hospitalizations, and end of life care will be extracted from the EHR. Clinical factors will be extracted prior to each interview to include in field notes associated with that data collection timepoint.

  At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)

• Focus groups

  Focus group session transcripts will undergo hybrid inductive-deductive thematic analysis to identify themes in participant reported needs and priorities, informing the development of intervention targets, format, and design. Sessions will be conducted according to the generative co-design framework for healthcare innovation and integrated with Photovoice procedures. Focus groups will be audio-recorded, professionally transcribed, and de-identified prior to analysis. Transcripts and associated metadata will be imported into a secure, password-protected qualitative data management software platform to facilitate mixed-methods analysis.

  At least 12 months after study enrollment

Secondary Outcomes (1)

• Semi-structured Interview with clinicians

  At 6 and 12 months (+/-4 weeks)

Study Arms (3)

Patient participants

Patient participants 12 to 25 years of age, with a primary cancer diagnosis that is relapsed, refractory, or without curative standard-of-care options and be enrolled OR planning to enroll in a phase 1 or phase 2 trial for cancer-directed therapy.

Caregiver participants

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, is enrolled OR planning to enroll on a phase 1 or phase 2 trial for cancer-directed therapy and is ≥ 18 years of age or legally emancipated.

Healthcare Clinician participants

A physician, advanced practice provider, or nurse providing direct patient care to the patient participant and/or to the child of the caregiver participant. A psychosocial clinician (e.g., social worker, psychologist, chaplain, child life specialist, music therapist, cultural navigator, etc.) who provides direct or consultative care to pediatric or adolescent/young adult patients with relapsed, refractory, or high-risk cancer and/or their families.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are 3 populations of participants in this study: patients 12-25 years of age, parent or primary caregiver of patient, and healthcare clinicians who meet the Eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• Patients, Caregivers, and Clinicians will be excluded if they:
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

• Alexandra Superdock, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Superdock, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 2, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)