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

Washington University School of Medicine60 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Hematologic Malignancy Solid Tumor Sickle Cell Disease Aplastic Anemia Immune Deficiency

Interventions

Let's Get REALBEHAVIORAL

Family health communication tool

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

Secondary Outcomes

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)

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)

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)

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.

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

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).

Central Contacts

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

CONTACT

314-454-6018 schulz_g@wustl.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

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.

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

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'.

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

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.

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

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".

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

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.

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

Number of patients who chose SCTCT

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