Improving Care Coordination for Adolescents and Young Adults With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586127
• Other study ID #: IRB00068240
• Secondary ID: P50CA244693P30CA
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: July 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	North Carolina Cancer Hospital	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 5
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.	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	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.	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.	Week 12
Secondary	Number of AYA Needs	Average number of needs reported by AYAs.	Week 12