Cancer
Conditions
Keywords
adolescents, care coordination, cancer care needs
Brief summary
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.
Detailed description
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.
Interventions
OTHERAYA NA-SB Questionnaire
Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* AYAs with cancer ages 18 through 39 currently undergoing cancer treatment at the North Carolina Cancer Hospital/ UNC Children's Hospital
Exclusion criteria
* Patients who decline to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) AYA | Week 5 | 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. |
| Acceptability of Intervention Measure (AIM) AYA | Week 12 | 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. |
| Intervention Appropriateness Measure (IAM) AYA | Week 5 | 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 |
| Number of Participants Who Received Services | Week 12 | 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. |
| Needs Met Questionnaire | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of AYA Needs | Week 12 | Average number of needs reported by AYAs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6 |
| Cancer diagnosis Breast | 3 Participants |
| Cancer diagnosis Cervical | 3 Participants |
| Cancer diagnosis Hodgkin Lymphoma | 1 Participants |
| Cancer diagnosis Leukemia | 9 Participants |
| Cancer diagnosis Male Reproductive | 2 Participants |
| Cancer diagnosis Non-Hodgkin Lymphoma | 1 Participants |
| Cancer diagnosis Other | 3 Participants |
| Cancer diagnosis Other female reproductive | 1 Participants |
| Cancer diagnosis Sarcoma | 3 Participants |
| Cohabitants Lives alone | 2 Participants |
| Cohabitants Other | 1 Participants |
| Cohabitants Parent(s) | 9 Participants |
| Cohabitants Roommate(s) | 4 Participants |
| Cohabitants Sibling(s) | 1 Participants |
| Cohabitants Spouse/partner | 9 Participants |
| Insurance source Employer/school | 10 Participants |
| Insurance source Medicaid | 6 Participants |
| Insurance source Medicare | 1 Participants |
| Insurance source Military/TRICARE | 1 Participants |
| Insurance source No insurance | 3 Participants |
| Insurance source Other | 1 Participants |
| Insurance source Parent | 2 Participants |
| Insurance source Self-pay | 1 Participants |
| Insurance source Spouse's employer/school | 1 Participants |
| Race/Ethnicity, Customized Hispanic (all races) | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic American Indian/Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 9 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 12 Participants |
| Race/Ethnicity, Customized OTHER | 3 Participants |
| School status In school | 7 Participants |
| School status Not in school | 19 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
| Stage at diagnosis 0 | 1 Participants |
| Stage at diagnosis I/II | 5 Participants |
| Stage at diagnosis III/IV | 5 Participants |
| Stage at diagnosis Unknown/ unstaged | 15 Participants |
| Time since diagnosis >12 months | 6 Participants |
| Time since diagnosis 3-6 months | 3 Participants |
| Time since diagnosis <3 months | 15 Participants |
| Time since diagnosis 7-12 months | 2 Participants |
| Working status Not working | 13 Participants |
| Working status Working | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: Week 12
Population: young adults with cancer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Acceptability of Intervention Measure (AIM) AYA | 4.5 units on a scale | Standard Deviation 0.5 |
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.
Time frame: Week 5
Population: young adults with cancer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Feasibility of Intervention Measure (FIM) AYA | 4.52 units on a scale | Standard Deviation 0.5 |
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
Time frame: Week 5
Population: young adults with cancer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Intervention Appropriateness Measure (IAM) AYA | 4.4 units on a scale | Standard Deviation 0.489 |
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.
Time frame: Week 12
Population: young adults with cancer who reported needs and reported receiving follow-up care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Needs Met Questionnaire | 3.7 units on a scale | Standard Deviation 1.6 |
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.
Time frame: Week 12
Population: young adults with cancer who reported needs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants Who Received Services | 13 Participants |
Secondary
Number of AYA Needs
Average number of needs reported by AYAs.
Time frame: Week 12
Population: young adults with cancer
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Number of AYA Needs | 13 needs reported |