Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Primary Purpose
Cancer, Cancer Metastatic, Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elly Mobile Phone Application
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Elly Health, Elly App
Eligibility Criteria
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.
Sites / Locations
- Cedars Sinai Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elly Mobile Phone Application
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Frequency of Elly app use
Frequency of study participant opening the Elly app
Elly app login amount
Number of logins to Elly app by study participant
Duration of Elly app use
Duration of each Elly app session by study participant
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04604158
Brief Title
Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Official Title
IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
July 8, 2022 (Anticipated)
Study Completion Date
July 8, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gillian Gresham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Elly Health, Elly App
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elly Mobile Phone Application
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Elly Mobile Phone Application
Other Intervention Name(s)
Elly App
Intervention Description
The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.
Primary Outcome Measure Information:
Title
Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
Description
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
Secondary Outcome Measure Information:
Title
Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.
Description
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
Title
Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.
Description
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
Title
Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.
Description
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
Title
Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.
Description
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
Title
Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.
Description
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
Title
Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 30 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 60 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 90 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 120 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 150 compared with baseline.
Description
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
Title
Absolute change in patient-reported depression scores at Day 180 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.
Description
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
Title
Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 30 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 60 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 90 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 120 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 150 compared with baseline.
Description
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
Title
Absolute change in patient-reported social isolation scores at Day 180 compared with baseline.
Description
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
Title
Frequency of Elly app use
Description
Frequency of study participant opening the Elly app
Time Frame
180 days
Title
Elly app login amount
Description
Number of logins to Elly app by study participant
Time Frame
180 days
Title
Duration of Elly app use
Description
Duration of each Elly app session by study participant
Time Frame
180 days
Title
Participant's experience with Elly app at Day 14-30.
Description
Participant's experience with Elly app based on qualitative interview done between Day 14-30.
Time Frame
Day 30
Title
Participant's experience with Elly app at Day 180-360.
Description
Participant's experience with Elly app based on qualitative interview done between Day 180-360.
Time Frame
Day 360
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gillian Gresham, PhD
Phone
310-423-3341
Email
gillian.gresham@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gillian Gresham
Phone
310-423-3341
Email
gillian.gresham@cshs.org
First Name & Middle Initial & Last Name & Degree
Gillian Gresham, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
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