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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244693 | U.S. NIH Grant/Contract | View source | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| 2T32CA122061 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to test an intervention designed to identify cancer needs and connect patients with services that address those needs. Participation in this research will involve completing 2 online surveys over the course of 1 month; each should take about 15 minutes to complete.
Adolescents and young Adults (AYA) Needs Assessment & Service Bridge (AYA NA-SB) includes a holistic Patient Reported Outcome Measures (PROM) assessing AYAs' physical, psychosocial and practical needs and a collection of referral pathways for connecting AYAs to services and resources based on the needs they report.
To assess the implementation of AYA NA-SB, the study team will pilot AYA NA-SB in the North Carolina Cancer Hospital (NCCH)/ UNC Children's Hospital, with a primary focus on implementation outcomes (i.e., feasibility, acceptability, appropriateness, fidelity). To establish proof-of-concept for AYA NA-SB, the study team will use pilot data to generate preliminary evidence on the extent to which AYA NA-SB addresses AYAs' reported needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents and Young Adults Needs Assessment & Service Bridge (AYA NA-SB) | Experimental | Subjects will complete 2 online surveys over the course of 1 month; each should take about 15 minutes to complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYA NA-SB Questionnaire | Other | Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Measure (FIM) AYA | Questionnaire measuring the extent to which AYA NA-SB can be successfully used in cancer programs. Score ranges from 1 to 5 with higher score denoting higher feasibility. | Week 5 |
| Acceptability of Intervention Measure (AIM) AYA | Questionnaire measuring perception of whether AYA-NA-SB is agreeable, palatable, or satisfactory to users. Score ranges from 1 to 5 with a higher score denoting higher acceptability. | Week 12 |
| Intervention Appropriateness Measure (IAM) AYA | Questionnaire measuring perception of AYA-NA-SB's fit, relevance, or compatibility with the context in which it will be used. Score ranges from 1 to 5 with a higher score denoting higher appropriateness | Week 5 |
| Number of Participants Who Received Services | Care coordination will be assessed by the proportion of Adolescents and Young Adults (AYAs) who reported needs who received services from across disciplines to address reported needs within one month of needs assessment completion. | Week 12 |
| Needs Met Questionnaire | Questionnaire assessing, among AYAs who reported needs and reported receiving follow-up care, AYAs' perception of the degree to which their needs were adequately addressed during the study period. Scores range from 1 to 5 where higher scores denote that needs were met. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of AYA Needs | Average number of needs reported by AYAs. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Haines, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Cancer Hospital | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | In this single-arm feasibility pilot, the treatment arm completed the NA-SB Needs Assessment at baseline through a secure online survey platform, REDCap. The 57 items assessing AYAs' physical, psychosocial, practical need were preceded by items collecting demographic and clinical information from respondents. AYAs received a $15 incentive for completing the needs assessment. An AYA social worker or AYA nurse practitioner then reviewed their NA-SB Needs Assessment with them, addressed any needs that fell within their purview, and initiated referral pathways for any remaining needs. One month following completion of the NA-SB needs assessment, we engaged AYA pilot participants in an electronic postintervention survey assessing their perceptions of NA-SB and whether their needs were met. The postintervention survey was administered through REDCap and AYAs received a second $15 incentive for completing it. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
young adults with cancer
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | In this single-arm feasibility pilot, the treatment arm completed the NA-SB Needs Assessment at baseline through a secure online survey platform, REDCap. The 57 items assessing AYAs' physical, psychosocial, practical need were preceded by items collecting demographic and clinical information from respondents. AYAs received a $15 incentive for completing the needs assessment. An AYA social worker or AYA nurse practitioner then reviewed their NA-SB Needs Assessment with them, addressed any needs that fell within their purview, and initiated referral pathways for any remaining needs. One month following completion of the NA-SB needs assessment, we engaged AYA pilot participants in an electronic postintervention survey assessing their perceptions of NA-SB and whether their needs were met. The postintervention survey was administered through REDCap and AYAs received a second $15 incentive for completing it. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Intervention Measure (FIM) AYA | Questionnaire measuring the extent to which AYA NA-SB can be successfully used in cancer programs. Score ranges from 1 to 5 with higher score denoting higher feasibility. | young adults with cancer | Posted | Mean | Standard Deviation | units on a scale | Week 5 |
|
from baseline up through 14 months
clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | In this single-arm feasibility pilot, the treatment arm completed the NA-SB Needs Assessment at baseline through a secure online survey platform, REDCap. The 57 items assessing AYAs' physical, psychosocial, practical need were preceded by items collecting demographic and clinical information from respondents. AYAs received a $15 incentive for completing the needs assessment. An AYA social worker or AYA nurse practitioner then reviewed their NA-SB Needs Assessment with them, addressed any needs that fell within their purview, and initiated referral pathways for any remaining needs. One month following completion of the NA-SB needs assessment, we engaged AYA pilot participants in an electronic postintervention survey assessing their perceptions of NA-SB and whether their needs were met. The postintervention survey was administered through REDCap and AYAs received a second $15 incentive for completing it. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Haines | Wake Forest University School of Medicine | (336) 716-5170 | ehaines@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2021 | Nov 30, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2021 | Sep 27, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Cancer diagnosis | Count of Participants | Participants |
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| Time since diagnosis | Count of Participants | Participants |
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| Stage at diagnosis | Participants self-reported cancer stage at diagnosis based on the information provided to them by their oncology care team. The "unknown/unstaged" option is for those who did not receive or remember receiving this information. Participants' respective physicians may have defined stages differently. In general, stage 0 is considered earliest/least advanced stage of cancer while stage IV describes most advanced cancer/ metastatic cancer. A higher stage represents more advanced cancer. | Count of Participants | Participants |
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| Insurance source | Count of Participants | Participants |
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| Cohabitants | Count of Participants | Participants |
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| School status | Count of Participants | Participants |
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| Working status | Count of Participants | Participants |
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| Primary | Acceptability of Intervention Measure (AIM) AYA | Questionnaire measuring perception of whether AYA-NA-SB is agreeable, palatable, or satisfactory to users. Score ranges from 1 to 5 with a higher score denoting higher acceptability. | young adults with cancer | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
| Primary | Intervention Appropriateness Measure (IAM) AYA | Questionnaire measuring perception of AYA-NA-SB's fit, relevance, or compatibility with the context in which it will be used. Score ranges from 1 to 5 with a higher score denoting higher appropriateness | young adults with cancer | Posted | Mean | Standard Deviation | units on a scale | Week 5 |
|
|
|
| Primary | Number of Participants Who Received Services | Care coordination will be assessed by the proportion of Adolescents and Young Adults (AYAs) who reported needs who received services from across disciplines to address reported needs within one month of needs assessment completion. | young adults with cancer who reported needs | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Primary | Needs Met Questionnaire | Questionnaire assessing, among AYAs who reported needs and reported receiving follow-up care, AYAs' perception of the degree to which their needs were adequately addressed during the study period. Scores range from 1 to 5 where higher scores denote that needs were met. | young adults with cancer who reported needs and reported receiving follow-up care | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
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| Secondary | Number of AYA Needs | Average number of needs reported by AYAs. | young adults with cancer | Posted | Mean | Inter-Quartile Range | needs reported | Week 12 |
|
|
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| 1 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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