Trial Outcomes & Findings for Improving Care Coordination for Adolescents and Young Adults With Cancer (NCT NCT04586127)
NCT ID: NCT04586127
Last Updated: 2024-01-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
Week 5
Results posted on
2024-01-12
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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21
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Care Coordination for Adolescents and Young Adults With Cancer
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=26 Participants
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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Age, Continuous
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29 years
STANDARD_DEVIATION 6 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic White
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12 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic Black
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9 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic (all races)
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Non-Hispanic American Indian/Alaska Native
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
OTHER
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3 Participants
n=5 Participants
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Cancer diagnosis
Leukemia
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9 Participants
n=5 Participants
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|
Cancer diagnosis
Breast
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3 Participants
n=5 Participants
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Cancer diagnosis
Cervical
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3 Participants
n=5 Participants
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Cancer diagnosis
Sarcoma
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3 Participants
n=5 Participants
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Cancer diagnosis
Male Reproductive
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2 Participants
n=5 Participants
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|
Cancer diagnosis
Non-Hodgkin Lymphoma
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1 Participants
n=5 Participants
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Cancer diagnosis
Hodgkin Lymphoma
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1 Participants
n=5 Participants
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Cancer diagnosis
Other female reproductive
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1 Participants
n=5 Participants
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|
Cancer diagnosis
Other
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3 Participants
n=5 Participants
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Time since diagnosis
<3 months
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15 Participants
n=5 Participants
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Time since diagnosis
3-6 months
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3 Participants
n=5 Participants
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Time since diagnosis
7-12 months
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2 Participants
n=5 Participants
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Time since diagnosis
>12 months
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6 Participants
n=5 Participants
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Stage at diagnosis
0
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1 Participants
n=5 Participants
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Stage at diagnosis
I/II
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5 Participants
n=5 Participants
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Stage at diagnosis
III/IV
|
5 Participants
n=5 Participants
|
|
Stage at diagnosis
Unknown/ unstaged
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15 Participants
n=5 Participants
|
|
Insurance source
Employer/school
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10 Participants
n=5 Participants
|
|
Insurance source
Spouse's employer/school
|
1 Participants
n=5 Participants
|
|
Insurance source
Parent
|
2 Participants
n=5 Participants
|
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Insurance source
Medicaid
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6 Participants
n=5 Participants
|
|
Insurance source
Medicare
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1 Participants
n=5 Participants
|
|
Insurance source
Military/TRICARE
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1 Participants
n=5 Participants
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|
Insurance source
No insurance
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3 Participants
n=5 Participants
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|
Insurance source
Self-pay
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1 Participants
n=5 Participants
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|
Insurance source
Other
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1 Participants
n=5 Participants
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Cohabitants
Lives alone
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2 Participants
n=5 Participants
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Cohabitants
Parent(s)
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9 Participants
n=5 Participants
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Cohabitants
Sibling(s)
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1 Participants
n=5 Participants
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Cohabitants
Spouse/partner
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9 Participants
n=5 Participants
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Cohabitants
Roommate(s)
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4 Participants
n=5 Participants
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Cohabitants
Other
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1 Participants
n=5 Participants
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School status
In school
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7 Participants
n=5 Participants
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School status
Not in school
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19 Participants
n=5 Participants
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Working status
Working
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13 Participants
n=5 Participants
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Working status
Not working
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13 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 5Population: young adults with cancer
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.
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
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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Feasibility of Intervention Measure (FIM) AYA
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4.52 units on a scale
Standard Deviation 0.50
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PRIMARY outcome
Timeframe: Week 12Population: young adults with cancer
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.
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
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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Acceptability of Intervention Measure (AIM) AYA
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4.5 units on a scale
Standard Deviation 0.5
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PRIMARY outcome
Timeframe: Week 5Population: young adults with cancer
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
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
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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Intervention Appropriateness Measure (IAM) AYA
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4.4 units on a scale
Standard Deviation 0.489
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PRIMARY outcome
Timeframe: Week 12Population: young adults with cancer who reported needs
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.
Outcome measures
| Measure |
Treatment Arm
n=16 Participants
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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Number of Participants Who Received Services
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13 Participants
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PRIMARY outcome
Timeframe: Week 12Population: young adults with cancer who reported needs and reported receiving follow-up care
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.
Outcome measures
| Measure |
Treatment Arm
n=13 Participants
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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Needs Met Questionnaire
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3.7 units on a scale
Standard Deviation 1.6
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SECONDARY outcome
Timeframe: Week 12Population: young adults with cancer
Average number of needs reported by AYAs.
Outcome measures
| Measure |
Treatment Arm
n=26 Participants
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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|---|---|
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Number of AYA Needs
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13 needs reported
Interval 2.0 to 21.0
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Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Emily Haines
Wake Forest University School of Medicine
Phone: (336) 716-5170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place