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

Not Applicable

Completed

• Conditions: Melanoma; Cancer; Cancer Metastatic; Sarcoma; Kidney Cancer; Leukemia; Head and Neck Cancer; Multiple Myeloma; Neoplasms; Loneliness
• Interventions: Behavioral: Elly Mobile Phone Application

• Registration Number: NCT04604158
• Lead Sponsor: Gillian Gresham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Study Start: 2020-12-02
• Status Verified: 2024-05
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elly Mobile Phone Application	Elly Mobile Phone Application	-

Primary Outcome Measures

Name	Time	Method
Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.	90 days	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.
Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.	14 days	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.
Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.	60 days	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.
Absolute change in patient-reported depression scores at Day 30 compared with baseline.	30 days	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.
Absolute change in patient-reported depression scores at Day 60 compared with baseline.	60 days	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.
Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.	30 days	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.
Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.	120 days	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.
Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.	150 days	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.
Absolute change in patient-reported depression scores at Day 150 compared with baseline.	150 days	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.
Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.	120 days	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.
Absolute change in patient-reported social isolation scores at Day 90 compared with baseline.	90 days	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.
Absolute change in patient-reported social isolation scores at Day 180 compared with baseline.	180 days	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.
Participant's experience with Elly app at Day 180-360.	Day 360	Participant's experience with Elly app based on qualitative interview done between Day 180-360.
Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.	180 days	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.
Absolute change in patient-reported depression scores at Day 90 compared with baseline.	90 days	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.
Absolute change in patient-reported depression scores at Day 120 compared with baseline.	120 days	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.
Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.	150 days	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.
Absolute change in patient-reported social isolation scores at Day 60 compared with baseline.	60 days	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.
Feasibility	180 days	Download of Elly app and engage with app at least 40% 3 or more times over study period.
Participant's experience with Elly app at Day 14-30.	Day 30	Participant's experience with Elly app based on qualitative interview done between Day 14-30.
Absolute change in patient-reported depression scores at Day 180 compared with baseline.	180 days	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.
Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.	60 days	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.
Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.	90 days	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.
Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.	180 days	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.
Absolute change in patient-reported social isolation scores at Day 120 compared with baseline.	120 days	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.
Absolute change in patient-reported social isolation scores at Day 150 compared with baseline.	150 days	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.
Elly app login amount (frequency and duration)	180 days	Number of logins to Elly app by study participant
Absolute change in patient-reported social isolation scores at Day 30 compared with baseline.	30 days	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.
Frequency of Elly app use	180 days	Frequency of study participant opening the Elly app

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States