Recruiting

Hope Support

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07444216

Conditions

Cancer, Therapy-Related

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

Brief 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 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.

Conditions

Cancer, Therapy-Related

Study ID

NCT07444216

Start date

Apr 9, 2026

Status verified date

Apr, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Longitudinal Hope-themed Photo-elicitation and Photo-narrative interview [ Time Frame: At enrollment, 3, 6, 9, and 12 months (+/-4 weeks) ]
  • Demographic survey [ Time Frame: At enrollment ]
  • Electronic medical record (EMR) Review [ Time Frame: At enrollment, 3, 6, 9, and 12 months (+/-4 weeks) ]
  • Focus groups [ Time Frame: At least 12 months after study enrollment ]

Central Contacts and Locations

Central contacts

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Principal Investigator:

Alexandra Superdock, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Photo-elicitation
  • Patient Participants
  • Parents/Caregivers
  • Clinicians
  • Interviews
  • Focus Groups

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-04-28.