Depression, Head and Neck Cancer, Head and Neck Cancers
Conditions
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.
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.
Interventions
BEHAVIORALIONA Mind app
The IONA Mind app is a smartphone app that delivers mental health support.
Sponsors
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Screening to Enrollment Ratio | baseline | Recruitment and Retention Tracking Tool will calculate the screening to enrollment ratio. |
| Feasibility: Measured by Retention Rate | 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 | up to 20 weeks | Minutes of app usage |
| Patient Health Questionnaire-9 (PHQ-9) | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREarlise Ward, MS, PhD, LP
University of Wisconsin, Madison
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
None listed