NCT07444216 · St. Jude Children's Research Hospital
A Longitudinal Photo-Narrative Exploration of Hope During Phase 1/2 Clinical Trials For Pediatric Cancer
What this study is about
The purpose of this study is to find better ways to help support families in their hopes during cancer treatment.
View original scientific description
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.
Primary outcome measures
Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview
Time frame: At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)
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.
Demographic survey
Time frame: At enrollment
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.
Electronic medical record (EMR) Review
Time frame: At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)
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.
Focus groups
Time frame: At least 12 months after study enrollment
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Memphis, Tennessee
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations