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Uma Exploração Foto-Narrativa Longitudinal da Esperança Durante Ensaios Clínicos de Fase 1/2 para Cancro Pediátrico

2 de novembro de 2026 atualizado por: St. Jude Children's Research Hospital

Compartilhando Esperança: Uma Exploração Longitudinal Foto-Narrativa da Esperança Durante os Ensaios Clínicos de Fase 1/2 para Cancro Pediátrico

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.

Visão geral do estudo

Status

Recrutamento

Condições

Câncer Relacionado à Terapia

Descrição detalhada

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).

Tipo de estudo

Observacional

Inscrição (Estimado)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Alexandra Superdock, MD
Número de telefone: 888-226-4343
E-mail: referralinfo@stjude.org

Locais de estudo

Estados Unidos
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38105
    - Recrutamento
    - St. Jude Children's Research Hospital
    - Investigador principal:
      
      Alexandra Superdock, MD
    - Contato:
      
      Alexandra Superdock, MD
      
      Número de telefone: 888-226-4343
      
      E-mail: referralinfo@stjude.org

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: COHORT
Perspectivas de Tempo: PROSPECTIVE

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview Prazo: 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.	At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)
Demographic survey Prazo: 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.	At enrollment
Electronic medical record (EMR) Review Prazo: 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.	At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)
Focus groups Prazo: 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.	At least 12 months after study enrollment

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Semi-structured Interview with clinicians Prazo: At 6 and 12 months (+/-4 weeks)	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.	At 6 and 12 months (+/-4 weeks)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St. Jude Children's Research Hospital

Colaboradores

National Cancer Institute (NCI)

Investigadores

Investigador principal: Alexandra Superdock, MD, St. Jude Children's Research Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de abril de 2026

Conclusão Primária (Estimado)

1 de março de 2028

Conclusão do estudo (Estimado)

1 de março de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

23 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ