Improving Care Coordination for Adolescents and Young Adults With Cancer

Improving Care Coordination for Adolescents and Young Adults With Cancer: Implementing a Bridge Between Needs and Services

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: AYA NA-SB Questionnaire

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • North Carolina Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AYA Needs	Average number of needs reported by AYAs.	Week 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Emily Haines, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): August 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: care coordination; adolescents; cancer care needs
• Other Study ID Numbers: IRB00068240; P30CA012197 (U.S. NIH Grant/Contract); P50CA244693 (U.S. NIH Grant/Contract); 2T32CA122061 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No