Mental Health App for Cancer Survivors Study

NCT06472726 | Terminated DMC

• 6 other identifiers: 2024-01115P50CA278595-07UW23133A532007SMPH/FAMILY MED/RES GRANTSProtocol version 2/10/2025
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Head and Neck Cancers; Depression

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

IONA Mind app

EXPERIMENTAL

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

Behavioral: IONA Mind app

Interventions

IONA Mind app BEHAVIORAL

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

IONA Mind app

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavioral Symptoms; Behavior

Study Officials

• Earlise Ward, MS, PhD, LP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

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: June 18, 2024
• First Posted: June 25, 2024
• Study Start: July 8, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)