Let's Get REAL: A Pilot Trial of a Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hematologic Malignancy
- Sponsor
- Washington University School of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility of intervention as measured by the Feasibility of Intervention questionnaire
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- Number of patients who chose SCTCT(Up to 4 weeks after SCTCT consultation (estimated to be week 8))