Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472726
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Mental Health App for Cancer Survivors Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Mental Health App for Cancer Survivors Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
MACS
Brief Summary:
The goal of this clinical trial is to adapt a mental health digital app to treat depression among head and neck cancer patients and survivors
Participants will download and use the digital mental health app for a 6-week period and will complete related surveys
Participants will download and use the digital mental health app for a 6-week period and will complete related surveys
Detailed Description:
This study is being done to estimate the feasibilityefficacyacceptability of the IONA Mind app for head and neck cancer HNC patients and survivors who show evidence of comorbid depression
IONA Mind is a digital app that delivers mental health support Once users sign up and respond to the initial assessment with PHQ-9 questionnaire it reaches out to users proactively to offer support personalized wellbeing plans and guidance
In partnership with the UWCCC the IONA Mind Team the Survey of the Health of Wisconsin SHOW and the Head Neck Patient Advocacy team the investigators propose adaptation of the IONA Mind app and pilot testing the app with 30 HNC patients and survivors Using a mixed method design the specific aims are
AIM 1 Adaptation of IONA Mind app for head and neck cancer The research team will iteratively adapt the IONA Mind app to provide psychological support for HNC patients and survivors The HNC Survivors Advisory Board will assist in identifying key aspects of the HNC survivors journey from diagnosis to the survivorship phase which will be prioritized and considered to iteratively redesign the IONA Mind phone app to better support HNC patients and survivors
AIM 2 Identify feasibility of the IONA Mind app for head and neck cancer The IONA Mind app will be tested with 30 HNC patients and survivors recruited from the Survey of the Health of Wisconsin SHOW recruitment registry and from the clinical practice at UW Carbone Cancer Center UWCCC
AIM 3 Determine preliminary efficacy IONA Mind app tailored for depression comorbid with head and neck cancer Clinical outcomes will be measured at baseline weekly for 6 weeks including the 6-week period of app utilization and post-intervention follow-up conducted at 1- and 3-month post intervention using validated tools to access depression
AIM 4 Determine satisfaction and acceptability of the IONA Mind app Satisfaction with the IONA Mind app will be measured with the System Usability Scale SUS delivered at 1-2 weeks following the completion of the app utilization In addition a qualitative interview for a random sub sample of 10 - 15 participants will occur shortly after completion of the intervention to assess satisfaction with and acceptability of the mobile app A head and neck patient and survivor phone app Low-Intensity Cognitive Behavioral Therapy LiCBT intervention to treat depression co-designed by HNC advocates mental health professionals and an expert technologist is a critical outcome of this research
IONA Mind is a digital app that delivers mental health support Once users sign up and respond to the initial assessment with PHQ-9 questionnaire it reaches out to users proactively to offer support personalized wellbeing plans and guidance
In partnership with the UWCCC the IONA Mind Team the Survey of the Health of Wisconsin SHOW and the Head Neck Patient Advocacy team the investigators propose adaptation of the IONA Mind app and pilot testing the app with 30 HNC patients and survivors Using a mixed method design the specific aims are
AIM 1 Adaptation of IONA Mind app for head and neck cancer The research team will iteratively adapt the IONA Mind app to provide psychological support for HNC patients and survivors The HNC Survivors Advisory Board will assist in identifying key aspects of the HNC survivors journey from diagnosis to the survivorship phase which will be prioritized and considered to iteratively redesign the IONA Mind phone app to better support HNC patients and survivors
AIM 2 Identify feasibility of the IONA Mind app for head and neck cancer The IONA Mind app will be tested with 30 HNC patients and survivors recruited from the Survey of the Health of Wisconsin SHOW recruitment registry and from the clinical practice at UW Carbone Cancer Center UWCCC
AIM 3 Determine preliminary efficacy IONA Mind app tailored for depression comorbid with head and neck cancer Clinical outcomes will be measured at baseline weekly for 6 weeks including the 6-week period of app utilization and post-intervention follow-up conducted at 1- and 3-month post intervention using validated tools to access depression
AIM 4 Determine satisfaction and acceptability of the IONA Mind app Satisfaction with the IONA Mind app will be measured with the System Usability Scale SUS delivered at 1-2 weeks following the completion of the app utilization In addition a qualitative interview for a random sub sample of 10 - 15 participants will occur shortly after completion of the intervention to assess satisfaction with and acceptability of the mobile app A head and neck patient and survivor phone app Low-Intensity Cognitive Behavioral Therapy LiCBT intervention to treat depression co-designed by HNC advocates mental health professionals and an expert technologist is a critical outcome of this research
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UW23133 | OTHER | None | None |
| A532007 | OTHER | None | None |
| SMPHFAMILY MEDRES GRANTS | OTHER | None | None |
| 5P50CA278595-07 | NIH | None | None |
| Protocol version 122024 | OTHER | None | None |