TerminatedNot Applicable

Mental Health App for Cancer Survivors Study

Stopped: App developer is no longer in business

United States1 participantsStarted 2025-07-08

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility: Screening to enrollment ratio

Timeframe: baseline

Feasibility: Measured by Retention rate

Timeframe: up to 20 weeks

Feasibility: IONA Mind app Utilization in Minutes

Timeframe: up to 20 weeks

Change in Patient Health Questionnaire-9 (PHQ-9)

Timeframe: 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

Timeframe: 2 weeks post-intervention (up to 8 weeks on study)

Qualitative Measure of Acceptability

Timeframe: 2 weeks post-intervention (up to 8 weeks on study)

Trial details

NCT IDNCT06472726

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-09

View on ClinicalTrials.gov More Head and Neck Cancer trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility: Screening to enrollment ratio

Timeframe: baseline

Feasibility: Measured by Retention rate

Timeframe: up to 20 weeks

Feasibility: IONA Mind app Utilization in Minutes

Timeframe: up to 20 weeks

Change in Patient Health Questionnaire-9 (PHQ-9)

Timeframe: 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

Timeframe: 2 weeks post-intervention (up to 8 weeks on study)

Qualitative Measure of Acceptability

Timeframe: 2 weeks post-intervention (up to 8 weeks on study)