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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50CA278595-07 | U.S. NIH Grant/Contract | View source | |
| UW23133 | Other Identifier | UW Madison | |
| A532007 | Other Identifier | UW Madison | |
| SMPH/FAMILY MED/RES GRANTS | Other Identifier | UW Madison | |
| Protocol version 2/10/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IONA Mind app | Experimental | Participants will be asked to use the IONA Mind app for a 6-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IONA Mind app | Behavioral | The IONA Mind app is a smartphone app that delivers mental health support. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Earlise Ward, MS, PhD, LP | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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) |