Head and Neck CancerMACSNCT06472726
Mental Health App for Cancer Survivors Study
A study testing IONA Mind app in people with Head and Neck Cancer and Head and Neck Cancers, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Cancers, Depression
- What is being tested?
- IONA Mind app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
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.
Read the 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
- Being tested
- IONA Mind app
- Medical subject headings
- Head and Neck Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IONA Mind appBehavioural
The IONA Mind app is a smartphone app that delivers mental health support.
| Study group | Role | What they receive |
|---|---|---|
| IONA Mind app | Experimental | Participants will be asked to use the IONA Mind app for a 6-week period. Receives: Behavioral: IONA Mind app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Screening to Enrollment Ratio
Recruitment and Retention Tracking Tool will calculate the screening to enrollment ratio.
Measured: baseline
Feasibility: Measured by Retention Rate
The Recruitment and Retention Tracking Tool will calculate the the number of participants who started the intervention and subsequently completed it.
Measured: up to 20 weeks
Feasibility: Number of Participants Recruited, Dropped Out, and Completed the Intervention
The Recruitment and Retention Tracking Tool will calculate the the number of participants who are recruited, dropped out, and complete the intervention.
Measured: up to 20 weeks
Feasibility: IONA Mind App Utilization in Minutes
Minutes of app usage
Measured: up to 20 weeks
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
Measured: 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.
Measured: 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.
Measured: 2 weeks post-intervention (up to 8 weeks on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start8 Jul 2025
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Why it stopped: App developer is no longer in business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Earlise Ward, MS, PhD, LP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472726
- Sponsor's protocol ID
- 2024-0111
- Other IDs
- 5P50CA278595-07, UW23133, A532007, SMPH/FAMILY MED/RES GRANTS, Protocol version 2/10/2025
- Acronym
- MACS
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health App for Cancer Survivors Study
- ClinicalTrials.gov ID
- NCT06472726
- Acronym / sponsor ID
- MACS / 2024-0111
- Conditions
- Head and Neck Cancer, Head and Neck Cancers, Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: App developer is no longer in business
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IONA Mind app | Experimental | Behavioral: IONA Mind appParticipants will be asked to use the IONA Mind app for a 6-week period. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IONA Mind appThe IONA Mind app is a smartphone app that delivers mental health support. | Behavioural | IONA Mind app |
Primary outcome
Feasibility: Screening to Enrollment Ratio
Time frame: baseline
Recruitment and Retention Tracking Tool will calculate the screening to enrollment ratio.
Feasibility: Measured by Retention Rate
Time frame: up to 20 weeks
The Recruitment and Retention Tracking Tool will calculate the the number of participants who started the intervention and subsequently completed it.
Feasibility: Number of Participants Recruited, Dropped Out, and Completed the Intervention
Time frame: up to 20 weeks
The Recruitment and Retention Tracking Tool will calculate the the number of participants who are recruited, dropped out, and complete the intervention.
Feasibility: IONA Mind App Utilization in Minutes
Time frame: up to 20 weeks
Minutes of app usage
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, weekly during intervention from weeks 1 through 6, 1-month post intervention, 3-month post intervention (up to 20 weeks in total)
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
Satisfaction Measured by System Usability Scale
Time frame: 2 weeks post-intervention (up to 8 weeks on study)
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.
Qualitative Measure of Acceptability
Time frame: 2 weeks post-intervention (up to 8 weeks on study)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earlise Ward, MS, PhD, LP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IONA Mind app in people with Head and Neck Cancer and Head and Neck Cancers, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Screening to Enrollment Ratio (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.