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Hematologic MalignancyNCT06689800

Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

A study testing Let's Get REAL in people with Hematologic Malignancy and Solid Tumor, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). Read more about this study

Who is it for?
Ages 8 years and older
What is being tested?
Let's Get REAL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
26 Nov 2024to 30 Nov 2026
Phase
Interventional
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 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Children or adolescents 8-17 years of age referred for SCTCT.
  • Diagnosis of malignant or nonmalignant disorder.
  • Referred for any type of SCTCT. Autologous and allogeneic stem cell and cellular therapies are eligible.
  • Planning to meet with a provider to discuss SCTCT.
  • Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed assent document.
  • Must speak English and be cognitively able to participate.
Show all 9Show fewer
  • Parent or guardian of a child 8-17 years of age with any diagnosis referred for any type of SCTCT. Diagnoses may include malignant and nonmalignant disorders. Autologous and allogeneic stem cell and cellular therapies are eligible. Parent or guardian is defined as an adult who usually cares for the youth and has authority to make medical decisions for them.
  • Must have the ability to understand and willingness to consent to participate after reviewing an IRB approved informed consent document.
  • Must speak English and be cognitively able to participate.

Who cannot join

  • Active medical problems severe enough to preclude study participation at the time of recruitment.
  • Patients who are otherwise eligible, but whose primary transplant physician does not want them to participate in the study.
  • Lacks cognitive capacity to complete study activities, as determined by consenting professional.
  • Their youth referred for SCTCT does not assent to participate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ginny L Schulz, Ph.D., RN, CPNP-PC contact

314-454-6018

schulz_g@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Ginny L Schulz, Ph.D., RN, CPNP-PC, 314-454-6018, schulz_g@wustl.edu

    Ginny L Schulz, Ph.D., RN, CPNP-PC

    Recruiting

Other trials in United States

About this study

Official title: Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy

The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).

Being tested
Let's Get REAL
Keywords
Pediatric, Family, Decision making, Health Communication, Intervention
Medical subject headings
Hematologic Neoplasms, Anemia, Sickle Cell, Anemia, Aplastic, Immunologic Deficiency Syndromes, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Let's Get REALBehavioural

    Family health communication tool

Study groups in NCT06689800
Study groupRoleWhat they receive
Let's Get REAL family health communication tool: Patients (8-12 years of age)ExperimentalPatients and parent(s) will be given the Let's Get REAL family health communication tool to use up to one month prior to their SCTCT consultation visit. It is a guide for pediatric patients and their families to learn about and discuss SCTCT. Participants will complete demographic and baseline surveys prior to using the tool, and then additional surveys up to one month after SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits will be audio-recorded. Participants may also participate in an optional semi-structured interview up to 8 weeks after SCTCT consultation.
Receives: Behavioral: Let's Get REAL
Let's Get REAL family health communication tool: Patients (13-17 years of age)ExperimentalPatients and parent(s) will be given the Let's Get REAL family health communication tool to use up to one month prior to their SCTCT consultation visit. It is a guide for pediatric patients and their families to learn about and discuss SCTCT. Participants will complete demographic and baseline surveys prior to using the tool, and then additional surveys up to one month after SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits will be audio-recorded. Participants may also participate in an optional semi-structured interview up to 8 weeks after SCTCT consultation.
Receives: Behavioral: Let's Get REAL
Let's Get REAL family health communication tool: ParentsExperimentalPatients and parent(s) will be given the Let's Get REAL family health communication tool to use up to one month prior to their SCTCT consultation visit. It is a guide for pediatric patients and their families to learn about and discuss SCTCT. Participants will complete demographic and baseline surveys prior to using the tool, and then additional surveys up to one month after SCTCT consultation visit and up to one month post-discharge from SCTCT. SCTCT consultation visits will be audio-recorded. Participants may also participate in an optional semi-structured interview up to 8 weeks after SCTCT consultation.
Receives: Behavioral: Let's Get REAL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of intervention as measured by the Feasibility of Intervention questionnaire

    This is a 4-item scale that youth and their parents report feasibility of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater feasibility.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  2. Acceptability of intervention as measured by the Acceptability of Intervention questionnaire

    This is a 4-item scale that youth and their parents report acceptability of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater acceptability.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  3. Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire

    This is a 4-item scale that youth and their parents report appropriateness of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater appropriateness.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  4. Feasibility of intervention as measured qualitatively

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of feasibility content codes.

    Measured: Up to 8 weeks after SCTCT consultation (estimated to be week 16)

  5. Acceptability of intervention as measured qualitatively

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of acceptability content codes.

    Measured: Up to 8 weeks after SCTCT consultation (estimated to be week 16)

  6. Appropriateness of intervention as measured qualitatively

    Content analysis of open-ended survey responses and quotations from individual interviews. Will be collecting number of appropriateness content codes.

    Measured: Up to 8 weeks after SCTCT consultation (estimated to be week 16)

Secondary outcomes (11)

  1. Difference in feasibility scores in those 8-12 years of age and those 13-17 years of age as measured by the Feasibility of Intervention questionnaire

    This is a 4-item scale that youth and their parents report feasibility of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater feasibility.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  2. Difference in acceptability scores in those 8-12 years of age and those 13-17 years of age as measured by the Acceptability of Intervention questionnaire

    This is a 4-item scale that youth and their parents report acceptability of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater acceptability.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  3. Difference in appropriateness scores in those 8-12 years of age and those 13-17 years of age as measured by the Intervention of Appropriateness questionnaire

    This is a 4-item scale that youth and their parents report appropriateness of the intervention on a 5-point Likert scale ranging from 'Completely disagree' to Completely agree'. A higher score indicates greater appropriateness.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  4. Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale

    This is a 30-item scale that youth and their parents report youth involvement behaviors in a decision related to their illness on a 4-point Likert scale ranging from 'A Little Bit' to 'A Lot'. The higher the subscale score (child seek, child express, parent seek, parent express, and joint/options), the more that behavior or type of involvement occurred in the decision making process.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  5. Observed levels of decision-making involvement in youth 8-17 years of age and their parents

    Number of utterance occurrences for the following: 1) who uttered (youth, parent), 2) was utterance prompted (yes/no), if so, by who, 3) type of utterance (questions, opinion, concern, other), and 4) content of utterance (prognosis, side effect, expectation).

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  6. Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale

    This is a 20-item scale that youth and parents report the degree of openness in family communication and the extent of problems with family communications on a 5-point Likert ranging from 'strongly disagree' to 'strongly agree'. A higher score on the degree of openness subscale indicates better communication between parent and adolescent. For extent of problems subscale, a higher score indicates more problems in the parent-child communication.

    Measured: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)

  7. Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy

    This is an 8-item scale that measures youth's general anxiety in those 8-17 years of age on a 5-point Likert scale ranging from 'never' to 'almost always'.

    Measured: Up to 4 weeks prior to SCTCT consultation and up to 4 weeks after SCTCT consultation (estimated to be 8 weeks)

  8. Level of decisional conflict as measured by the Likert-type Decisional Conflict Scale

    This is a 10-item scale that youth and parents report their personal uncertainty and decisional conflict related to a specific decision. We are using the question format as it is recommended for those with limited reading or response skills. They respond 'Yes', 'No, or 'Unsure'. A total decision conflict score ranges from 0 (no decisional conflict) to 100 (extremely high decision conflict). Higher scores on subscales uncertainty, informed, values clarity, and support reflect feeling extremely uncertain about the best choice, feeling extremely uninformed, feeling extremely unclear about personal values, and feeling extremely unsupported in decision making respectively.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  9. Youth-parent congruence of youth decision making involvement as measured by two Likert type statements

    Number of dyads that agree on these two statements measured on a 4-point Likert scale ranging from 'Not at all' to 'A lot': 1)"I/my child should be involved in future talks about transplant" and 2) "I/my child wants to be involved in future talks about transplant".

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  10. Satisfaction with the decision making involvement as measured by one Likert type statement

    This is a one item statement, "I am satisfied with my/my child's involvement in the transplant decision making process", measured on a 4-point Likert scale ranging from 'Not at all' to 'A lot'. A higher score indicates more satisfaction.

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

  11. Number of patients who chose SCTCT

    Measured: Up to 4 weeks after SCTCT consultation (estimated to be week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start26 Nov 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689800
Sponsor's protocol ID
202410119
Other IDs
K12CA167540
Status last verified
Jun 2026
First submitted
12 Nov 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Let's Get REAL in people with Hematologic Malignancy and Solid Tumor, run by Washington University School of Medicine 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 9 inclusion and 4 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 Jun 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 Ginny L Schulz, Ph.D., RN, CPNP-PC (314-454-6018, schulz_g@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of intervention as measured by the Feasibility of Intervention questionnaire (time frame: Up to 4 weeks after SCTCT consultation (estimated to be week 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06689800.

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 Jun 2026.

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