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

May 17, 2024 updated by: Gillian Gresham

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elly Mobile Phone Application
Behavioral: Elly Mobile Phone Application
The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.
Other Names:
  • Elly App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
Time Frame: 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.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gillian Gresham

Investigators

  • Principal Investigator: Gillian Gresham, PhD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

May 17, 2024

Study Completion (Actual)

May 17, 2024

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2020-13-GRESHAM-ELLY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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