Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191679
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2023-12-20
Brief Title:
Decision Aid for Education and Support About Cancer Treatment
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Decision Aid for Education and Support About Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIDES B
Brief Summary:
The goals of this clinical trial are to evaluate DECIDES a web-based decision support application that provides education about cancer and cancer treatment and provides support to encourage adolescent and young adult AYA patients their caregivers and oncology health care providers to make informed decisions about cancer treatment together
The main questions this study aims to answer are
Is DECIDES acceptable usable and feasible for AYA caregivers and oncology health care providers
Is DECIDES helpful for AYA caregivers and oncology health care providers that are making cancer treatment decisions together
AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups 1 Usual Care 2 DECIDES or 3 DECIDES Coach Participants in Usual Care will continue to have access to their oncology health care team for questions related to cancer and cancer treatment as per usual standard of care Participants in both DECIDES and DECIDES Coach groups will receive access to DECIDES and those in DECIDES Coach will receive additional live coach-assisted support After 8 weeks AYA and caregivers will complete a follow-up questionnaire and those in the DECIDES and DECIDES Coach groups will complete a semi-structured qualitative interview Oncology health care providers of participating AYA will be invited to participate in a questionnaire and semi-structured qualitative interview Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES with and without coach-assisted support report more positive decision-making processes compared to those that receive usual standard of care
The main questions this study aims to answer are
Is DECIDES acceptable usable and feasible for AYA caregivers and oncology health care providers
Is DECIDES helpful for AYA caregivers and oncology health care providers that are making cancer treatment decisions together
AYA and caregiver participants will complete a questionnaire and be randomly assigned to participate in one of three groups 1 Usual Care 2 DECIDES or 3 DECIDES Coach Participants in Usual Care will continue to have access to their oncology health care team for questions related to cancer and cancer treatment as per usual standard of care Participants in both DECIDES and DECIDES Coach groups will receive access to DECIDES and those in DECIDES Coach will receive additional live coach-assisted support After 8 weeks AYA and caregivers will complete a follow-up questionnaire and those in the DECIDES and DECIDES Coach groups will complete a semi-structured qualitative interview Oncology health care providers of participating AYA will be invited to participate in a questionnaire and semi-structured qualitative interview Researchers will compare groups to see if AYA and caregivers that receive access to DECIDES with and without coach-assisted support report more positive decision-making processes compared to those that receive usual standard of care
Detailed Description:
DECIDES is a developmentally appropriate engaging and interactive web-based decision support application that has been designed to address health literacy and includes
Education on cancer and cancer treatments including clinical trials
An exercise to identify perceived barriers and benefits to treatment options
An exercise to clarify personal goals for treatment that align with life goals
Resources to support communication with the oncology health care team
Education on cancer and cancer treatments including clinical trials
An exercise to identify perceived barriers and benefits to treatment options
An exercise to clarify personal goals for treatment that align with life goals
Resources to support communication with the oncology health care team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None