Mental Health App for Cancer Survivors Study (MACS)

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Head and Neck Cancer; Head and Neck Cancers
• Intervention / Treatment: Behavioral: IONA Mind app

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IONA Mind app; Participants will be asked to use the IONA Mind app for a 6-week period.	Behavioral: IONA Mind app; The IONA Mind app is a smartphone app that delivers mental health support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Screening to enrollment ratio	Recruitment and Retention Tracking Tool will calculate the screening to enrollment ratio.	baseline
Feasibility: Measured by Retention rate	The Recruitment and Retention Tracking Tool will calculate the the number of participants who are recruited, dropped out, and complete the intervention.	up to 20 weeks
Feasibility: IONA Mind app Utilization in Minutes	Minutes of app usage	up to 20 weeks
Change in Patient Health Questionnaire-9 (PHQ-9)	Clinical outcomes will be measured at baseline, weekly for 6 weeks during app utilization, and at post-intervention follow-up conducted at 1- and 3-month post intervention using the PHQ-9. The PHQ-9 is a 9-item scale assessing depression. It is scored on a 0- to 3-point Likert scale where 0=Not at all and 3 = nearly every day. Mean scores are reported for a range from 0-27 where higher scores indicate greater levels of depression	baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)
Satisfaction Measured by System Usability Scale	The System Usability Scale is a 10-item questionnaire assessing participants' satisfaction with the IONA Mind app. It is scored on a 1- to5-point Likert scale where 1= strongly disagree and 5= strongly agree. Mean item scores are reported with a range from 10 to 50 where higher scores indicate greater satisfaction with the app.	2 weeks post-intervention (up to 8 weeks on study)
Qualitative Measure of Acceptability	Ascertained via a qualitative semi-structured interview for a random subsample of 10 - 15 participants after completion of the intervention (1-2 weeks post-intervention). Interview answers with be coded for thematic analysis and reported by participant count.	2 weeks post-intervention (up to 8 weeks on study)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Earlise Ward, MS, PhD, LP, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Behavior; Depression; Head and Neck Neoplasms
• Other Study ID Numbers: 2024-0111; A532007 (Other Identifier: UW- Madison); SMPH/FAMILY MED/RES GRANTS (Other Identifier: UW- Madison); UW23133 (Other Identifier: UW Madison); 5P50CA278595-07 (U.S. NIH Grant/Contract); Protocol version 2/10/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No