Cancer, Therapy-RelatedNCT07444216
A Longitudinal Photo-Narrative Exploration of Hope During Phase 1/2 Clinical Trials For Pediatric Cancer
An observational study of Cancer, Therapy-Related, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cancer, Therapy-Related
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Alexandra Superdock, MD, 888-226-4343, referralinfo@stjude.org
Alexandra Superdock, MD
About this study
Official title: 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
Read more
- 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.
Read the detailed description
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).
- Conditions
- Cancer, Therapy-Related
- Keywords
- Photo-elicitation, Patient Participants, Parents/Caregivers, Clinicians, Interviews, Focus Groups
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At least 12 months after study enrollment
Secondary outcomes (1)
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.
Measured: At 6 and 12 months (+/-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start9 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Therapy-RelatedStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexandra Superdock, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444216
- Sponsor's protocol ID
- SHAREHOPE
- Other IDs
- 5K12CA270369, NCI-2026-01388
- Status last verified
- Nov 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharing Hope: A Longitudinal Photo-Narrative Exploration of Hope During Phase 1/2 Clinical Trials For Pediatric Cancer
- ClinicalTrials.gov ID
- NCT07444216
- Acronym / sponsor ID
- SHAREHOPE
- Conditions
- Cancer, Therapy-Related
- Keywords
- Photo-elicitation, Patient Participants, Parents/Caregivers, Clinicians, Interviews, Focus Groups
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (21 listed)
- 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:
- AND
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Semi-structured Interview with clinicians
Time frame: At 6 and 12 months (+/-4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Superdock, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Therapy-Related, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Superdock, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview (time frame: At enrollment, 3, 6, 9, and 12 months (+/-4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.