Mental Health App for Cancer Survivors Study

NCT ID: NCT06472726

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2026-02-28

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.

Detailed Description

This study is being done to estimate the feasibility/efficacy/acceptability 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.

Conditions

Head and Neck Cancer; Head and Neck Cancers; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IONA Mind app

Participants will be asked to use the IONA Mind app for a 6-week period.

Group Type: EXPERIMENTAL

IONA Mind app

Intervention Type: BEHAVIORAL

The IONA Mind app is a smartphone app that delivers mental health support.

Interventions

IONA Mind app

The IONA Mind app is a smartphone app that delivers mental health support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of HNC confirmed by histopathologic diagnosis. The signed report must be available on electronic health record (EHR) for participants who received treatment or follow-up at University of Wisconsin Carbone Cancer Center (UWCCC). Alternatively, participants must have a printed signed report if received treatment out of UWCCC
• Age greater than or equal to 22 years at the time of consent
• Patient Health Questionnaire-9 (PHQ-9) score ≥ 5 and ≤ 19 (moderate and severely moderate depression)
• Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

• Unable to read and speak English.
• Utilization of prescription medicine for depression.
• Patient Health Questionnaire-9 (PHQ-9) score of greater than or equal to 20 (severe depression)
• Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 1 on the suicidal question (question 9)
• Pregnant people

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Earlise Ward, MS, PhD, LP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

5P50CA278595-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UW23133

Identifier Type: OTHER

Identifier Source: secondary_id

A532007

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/FAMILY MED/RES GRANTS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol version 2/10/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0111

Identifier Type: -

Identifier Source: org_study_id