NCT04586127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 12, 2024

Completed
Last Updated

January 12, 2024

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

October 7, 2020

Results QC Date

December 1, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

adolescentscare coordinationcancer care needs

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Number of AYA Needs

    Week 12

Study Arms (1)

Adolescents and Young Adults Needs Assessment & Service Bridge (AYA NA-SB)

EXPERIMENTAL

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

Interventions

Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them.

Adolescents and Young Adults Needs Assessment & Service Bridge (AYA NA-SB)

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • AYAs with cancer ages 18 through 39 currently undergoing cancer treatment at the North Carolina Cancer Hospital/ UNC Children's Hospital

You may not qualify if:

  • Patients who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Emily Haines
Organization
Wake Forest University School of Medicine

Study Officials

  • Emily Haines, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

June 15, 2021

Primary Completion

August 26, 2022

Study Completion

August 26, 2022

Last Updated

January 12, 2024

Results First Posted

January 12, 2024

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations