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

St. Jude Children's Research Hospital100 enrolled

Overview

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).

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At least 12 months after study enrollment

Secondary Outcomes

Semi-structured Interview with clinicians

Clinician interviews provide an opportunity for clinicians to reflect on patient and caregiver experiences in a new way by reviewing their photo-narrative document (if the participant agrees). Clinician interviews and electronic medical record data will be used to triangulate findings from semi-structured photo-narrative interviews with patients and caregivers, enriching 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.

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

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts