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| ID | Type | Description | Link |
|---|---|---|---|
| K12CA167540 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| St. Louis Children's Hospital Foundation | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Let's Get REAL family health communication tool: Patients (8-12 years of age) | Experimental | Patients 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. |
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| Let's Get REAL family health communication tool: Patients (13-17 years of age) | Experimental | Patients 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. |
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| Let's Get REAL family health communication tool: Parents | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Let's Get REAL | Behavioral | Family health communication tool |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 8 weeks after SCTCT consultation (estimated to be week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 weeks after SCTCT consultation (estimated to be week 8) |
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Inclusion Criteria Youth:
Inclusion Criteria Parents:
Exclusion Criteria Youth:
Active medical problems severe enough to preclude study participation at the time of recruitment.
Lacks cognitive capacity to complete study activities, as determined by consenting professional.
Exclusion Criteria Parents:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ginny L Schulz, Ph.D., RN, CPNP-PC | Contact | 314-454-6018 | schulz_g@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ginny Schulz, Ph.D., RN, CPNP-PC | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| 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. | Up to 8 weeks after SCTCT consultation (estimated to be week 16) |
| 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. | 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 | 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. | 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. | 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). | 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. | 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'. | 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. | 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". | 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. | 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) |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000755 | Anemia, Sickle Cell |
| D000741 | Anemia, Aplastic |
| D007153 | Immunologic Deficiency Syndromes |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D007154 | Immune System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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