Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients

Study Overview
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Brief Summary
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This is a single-arm, prospective, interventional study in cancer survivors and patients to examine the feasibility of a mobile health application, Elly (Elly Health Inc.), to reduce levels of anxiety, stress, loneliness, and social isolation. Participants will be given access to the Elly phone application developed by Elly Health Inc. and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.

Official Title
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IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients

Conditions
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Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Glioblastoma, Prostate Cancer, Gynecologic Cancer, Colorectal Cancer, Sarcoma, Kidney Cancer, Bladder Cancer, Lymphoma, Leukemia, Head and Neck Cancer, Pancreas Cancer, Multiple Myeloma, Anxiety, Social Isolation, Stress, Loneliness, Melanoma, Uterine Cancer

Intervention / Treatment
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* Behavioral: Elly Mobile Phone Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer of any type and currently receiving cancer-targeted treatment or have received cancer-targeted treatment within 6 months of consent date based on self-report. Cancer-targeted treatment includes chemotherapy, radiation therapy, hormonal therapy, biologic therapy, immunotherapy, and surgery. 18 years or older Access to and ability to use an iPhone (SE+, iOS 12.4+) Ability to understand and read English Have an understanding, ability, and willingness to fully comply with study procedures and restrictions Exclusion Criteria: - Hearing loss or vision impairment that would preclude the participant from accessing and using the app (use of hearing aids or visual aids is acceptable) based on self-report.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elly Mobile Phone Application<br> | Behavioral: Elly Mobile Phone Application<br>* The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.<br>* Other names: Elly App;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in patient-reported anxiety scores at Day 30 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in patient-reported anxiety scores at Day 14 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 14 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 14 days | 
| Absolute change in patient-reported anxiety scores at Day 60 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 60 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 60 days | 
| Absolute change in patient-reported anxiety scores at Day 90 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 90 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 90 days | 
| Absolute change in patient-reported anxiety scores at Day 120 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 120 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 120 days | 
| Absolute change in patient-reported anxiety scores at Day 150 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 150 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 150 days | 
| Absolute change in patient-reported anxiety scores at Day 180 compared with baseline. | Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 180 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome. | 180 days | 
| Absolute change in patient-reported depression scores at Day 30 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 30 days | 
| Absolute change in patient-reported depression scores at Day 60 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 60 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 60 days | 
| Absolute change in patient-reported depression scores at Day 90 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 90 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 90 days | 
| Absolute change in patient-reported depression scores at Day 120 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 120 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 120 days | 
| Absolute change in patient-reported depression scores at Day 150 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 150 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 150 days | 
| Absolute change in patient-reported depression scores at Day 180 compared with baseline. | Absolute change in patient-reported depression scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 180 compared with baseline. The minimum value is 8 and maximum value is 40, and a lower score means a better outcome. | 180 days | 
| Absolute change in patient-reported loneliness scores at Day 30 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 30 days | 
| Absolute change in patient-reported loneliness scores at Day 60 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 60 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 60 days | 
| Absolute change in patient-reported loneliness scores at Day 90 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 90 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 90 days | 
| Absolute change in patient-reported loneliness scores at Day 120 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 120 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 120 days | 
| Absolute change in patient-reported loneliness scores at Day 150 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 150 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 150 days | 
| Absolute change in patient-reported loneliness scores at Day 180 compared with baseline. | Absolute change in patient-reported loneliness scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 180 compared with baseline. The minimum value is 5 and maximum value is 25, and a lower score means a better outcome. | 180 days | 
| Absolute change in patient-reported social isolation scores at Day 30 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 30 days | 
| Absolute change in patient-reported social isolation scores at Day 60 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 60 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 60 days | 
| Absolute change in patient-reported social isolation scores at Day 90 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 90 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 90 days | 
| Absolute change in patient-reported social isolation scores at Day 120 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 120 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 120 days | 
| Absolute change in patient-reported social isolation scores at Day 150 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 150 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 150 days | 
| Absolute change in patient-reported social isolation scores at Day 180 compared with baseline. | Absolute change in patient-reported social isolation scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 180 compared with baseline. The minimum value is 4 and maximum value is 20, and a lower score means a better outcome. | 180 days | 
| Frequency of Elly app use | Frequency of study participant opening the Elly app | 180 days | 
| Elly app login amount | Number of logins to Elly app by study participant | 180 days | 
| Duration of Elly app use | Duration of each Elly app session by study participant | 180 days | 
| Participant's experience with Elly app at Day 14-30. | Participant's experience with Elly app based on qualitative interview done between Day 14-30. | Day 30 | 
| Participant's experience with Elly app at Day 180-360. | Participant's experience with Elly app based on qualitative interview done between Day 180-360. | Day 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elly Health, Elly App