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

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

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.

This is an observational study where findings will inform the future development of an intervention; this study itself does not involve the implementation or testing of an intervention. The research methods used to obtain observational data are photo-narrative interviews and focus groups.

• Semi-structured participant-generated photo-elicitation interviews: At enrollment, participants will receive guidance on the structure, format, and purpose of photo-elicitation (also called photo-narrative or photovoice) interviews. Prior to each interview, participants will receive guidance in selecting 1-5 photos that represent their experience of hope at that time. After the participant shares their photographs and general reflections, they will work with the interviewer to complete a brief template to describe what they are hoping for, what is sustaining their hope, what is challenging their hope, and what they most want others to understand about their hope right now. Interviews will be conducted by a trained researcher with expertise in qualitative data collection and use of photo-elicitation methods, either in-person or virtually at the participant's discretion. Family units (dyads) will be offered an opportunity to engage in the interview together or individually, at their discretion.
• Semi-structured interviews with clinicians: Semi-structured interviews with clinicians will be conducted. With participants' permission, the interviewer will share participants' photos and templated narratives with the clinician. The interview guide will ask clinicians to share their reactions to and reflections on participants' photos and templated narratives. Interviews will be conducted in-person or virtually.
• Focus Groups: Focus groups will be structured according to the AHEAD (Approach to Human-centered, Evidence-driven Adaptive Design) framework. Participants (patients, caregivers, and multidisciplinary clinicians) will convene across two sets of focus groups to develop and refine a supportive care intervention centered on hope. The first focus group session will focus on identifying existing strengths (e.g., approaches that support diverse, evolving hope over time) and gaps (opportunities for improved support or timepoints of greatest need) as well as include facilitated brainstorming regarding possible solutions to target identified gaps. The second set of focus groups will center on collaborative review and refinement of intervention prototypes.
• Patient participants demographics and clinical contextual factors will be collected from the electronic medical record (EHR).

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.