Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
- Conditions
- Hematologic MalignancySolid TumorSickle Cell DiseaseAplastic AnemiaImmune DeficiencyMetabolic Disorder
- Registration Number
- NCT06689800
- Lead Sponsor
- Washington University School of Medicine
- Brief 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). 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility of intervention as measured by the Feasibility of Intervention questionnaire 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.
Acceptability of intervention as measured by the Acceptability of Intervention questionnaire 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.
Appropriateness of intervention as measured by the Intervention of Appropriateness questionnaire 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.
Feasibility of intervention as measured qualitatively 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.
Acceptability of intervention as measured qualitatively 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.
Appropriateness of intervention as measured qualitatively 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 Outcome Measures
Name Time Method 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 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.
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 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.
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 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.
Perceived levels of decision-making involvement in youth 8-17 years of age and their parents as measured by the Decision Making Involvement Scale 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.
Observed levels of decision-making involvement in youth 8-17 years of age and their parents 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).
Change in youth-parent communication as measured by the Likert-type Parent-Adolescent Communication Scale 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.
Change in the level of youth's general anxiety as measured by the Likert-type PROMIS Anxiety 8a Short Form or parent proxy 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'.
Level of decisional conflict as measured by the Likert-type Decisional Conflict Scale 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.
Youth-parent congruence of youth decision making involvement as measured by two Likert type statements 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".
Satisfaction with the decision making involvement as measured by one Likert type statement 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.
Number of patients who chose SCTCT Up to 4 weeks after SCTCT consultation (estimated to be week 8)
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States