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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.
Cedars Sinai Medical Center
Los Angeles, California, United States
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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 days
Frequency of Elly app use
Frequency of study participant opening the Elly app
Time frame: 180 days
Elly app login amount (frequency and duration)
Number of logins to Elly app by study participant
Time frame: 180 days
Feasibility
Download of Elly app and engage with app at least 40% 3 or more times over study period.
Time frame: 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.
Time frame: 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.
Time frame: Day 360
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.