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Une Exploration Longitudinale Photo-Narrative de l'Espoir Durant les Essais Cliniques de Phase 1/2 pour le Cancer Pédiatrique

2 novembre 2026 mis à jour par: St. Jude Children's Research Hospital

Partager l'Espoir : Une Exploration Photo-Narrative Longitudinale de l'Espoir Durant les Essais Cliniques de Phase 1/2 pour le Cancer Pédiatrique

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Cancer, lié à la thérapie

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Alexandra Superdock, MD
Numéro de téléphone: 888-226-4343
E-mail: referralinfo@stjude.org

Lieux d'étude

États-Unis
- Tennessee
  - Memphis, Tennessee, États-Unis, 38105
    - Recrutement
    - St. Jude Children's Research Hospital
    - Chercheur principal:
      
      Alexandra Superdock, MD
    - Contact:
      
      Alexandra Superdock, MD
      
      Numéro de téléphone: 888-226-4343
      
      E-mail: referralinfo@stjude.org

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: COHORT
Perspectives temporelles: PROSPECTIVE

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview Délai: 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 Délai: 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 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Semi-structured Interview with clinicians Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

St. Jude Children's Research Hospital

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 avril 2026

Achèvement primaire (Estimé)

1 mars 2028

Achèvement de l'étude (Estimé)

1 mars 2030

Dates d'inscription aux études

Première soumission

23 février 2026

Première soumission répondant aux critères de contrôle qualité