Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06689800

Let's Get REAL: 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hematologic Malignancy Anemia Anemia, Aplastic Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Aplastic Anemia Bone Marrow Diseases Bone Marrow Failure Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemoglobinopathies Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Metabolic Diseases Metabolic Disorder Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Sickle Cell Disease Solid Tumor

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Amy McQueen, Ph.D.

SUB_INVESTIGATOR

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

CONTACT

[email protected]

314-454-6018

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

PRINCIPAL_INVESTIGATOR

Shalini Shenoy, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Youth:

  • 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.

Inclusion criteria

Parents:

  • 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.

Exclusion criteria

Youth:

  • 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.

Exclusion criteria

Parents:

  • Their youth referred for SCTCT does not assent to participate.

Treatment and study plan

Let's Get REAL

Behavioral

Family health communication tool

Primary outcomes

  1. 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)

    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.

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

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

    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.

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

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

    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.

  4. Feasibility of intervention as measured qualitatively

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

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

  5. Acceptability of intervention as measured qualitatively

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

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

  6. Appropriateness of intervention as measured qualitatively

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

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

Secondary outcomes

  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

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

    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.

  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

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

    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.

  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

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

    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.

  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

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

    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.

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

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

    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).

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

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

    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.

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

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

    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'.

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

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

    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.

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

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

    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".

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

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

    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.

  11. Number of patients who chose SCTCT

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

314-454-6018

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • St. Louis Children's Hospital Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.