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

Sponsor

Gillian Gresham (Other)

Overall Status

Recruiting

CT.gov ID

NCT04604158

Collaborator

(none)

100

Enrollment

Location

Arm

19.2

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: Elly Mobile Phone Application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 2, 2020

Anticipated Primary Completion Date :

Jul 8, 2022

Anticipated Study Completion Date :

Jul 8, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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.
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 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.
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.
Frequency of Elly app use [180 days]
Frequency of study participant opening the Elly app
Elly app login amount [180 days]
Number of logins to Elly app by study participant
Duration of Elly app use [180 days]
Duration of each Elly app session by study participant
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.