Improving Care Coordination for Adolescents and Young Adults With Cancer

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04586127
Collaborator
(none)
26
1
1
13.5
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: AYA NA-SB Questionnaire
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Improving Care Coordination for Adolescents and Young Adults With Cancer: Implementing a Bridge Between Needs and Services
Actual Study Start Date :
Jun 15, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adolescents and Young Adults Needs Assessment & Service Bridge (AYA NA-SB)

Subjects will complete 2 online surveys over the course of 1 month; each should take about 15 minutes to complete.

Other: AYA NA-SB Questionnaire
Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Feasibility of Intervention Measure (FIM) Provider [Week 12]

    Questionnaire measuring the extent to which AYA NA-SB can be successfully used in cancer programs. Score ranges from 1 to 5 with a higher score denoting higher feasibility.

  3. 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.

  4. Acceptability of Intervention Measure (AIM) Provider [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.

  5. 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

  6. Intervention Appropriateness Measure (IAM) Provider [Week 12]

    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

  7. Fidelity-Proportion of Needs Assessment Reviewed by Provider [Week 12]

    Fidelity assessed by proportion of needs assessment reviewed by provider within one week

  8. Fidelity-Number of Referral Pathways Initiated [Week 12]

    Fidelity assessed by number of referral pathways Initiated

  9. Proportion of AYAs Who Received Services [Week 12]

    Care coordination will be assessed by the proportion of AYAs who received services from across disciplines to address reported needs within one month of needs assessment completion.

  10. Needs Met Questionnaire [Week 12]

    Questionnaire assessing 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 Outcome Measures

  1. Qualitative analysis of perceived determinants based on CFIR constructs [Week 12]

    Interviews will be coded by constructs from the Consolidated Framework of Implementation Research (CFIR) to report identified barriers and their perceived level of influence.

  2. Qualitative analysis of strategies used and their perceived level of influence [Week 12]

    Interviews will be analyzed inductively to report on implementation strategies used and their perceived level of influence.

  3. Number of AYA Needs by Domain [Week 12]

    Number of AYAs reporting needs in each of 9 domains

  4. Number of Services rendered [Week 12]

    services and resources rendered in response to needs reported by AYAs

  5. Frequency of AYA needs reported by item [Week 12]

    number of AYAs reporting each need

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Carolina Cancer Hospital Chapel Hill North Carolina United States 27514

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Emily Haines, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04586127
Other Study ID Numbers:
  • IRB00068240
First Posted:
Oct 14, 2020
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Aug 2, 2022