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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604158
• Other study ID #: IIT2020-13-GRESHAM-ELLY
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: May 17, 2024

Study information

• Verified date: May 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 17, 2024
• Est. primary completion date: May 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Bladder Cancer
• Breast Cancer
• Cancer
• Cancer Metastatic
• Colorectal Cancer
• Glioblastoma
• Gynecologic Cancer
• Head and Neck Cancer
• Kidney Cancer
• Kidney Neoplasms
• Leukemia
• Loneliness
• Lung Cancer
• Lymphoma
• Melanoma
• Multiple Myeloma
• Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Sarcoma
• Social Isolation
• Stress
• Uterine Cancer
• Uterine Neoplasms

Intervention

Behavioral:
• Elly Mobile Phone Application
The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Gillian Gresham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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.	14 days
Secondary	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.	60 days
Secondary	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.	90 days
Secondary	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.	120 days
Secondary	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.	150 days
Secondary	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.	180 days
Secondary	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.	30 days
Secondary	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.	60 days
Secondary	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.	90 days
Secondary	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.	120 days
Secondary	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.	150 days
Secondary	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.	180 days
Secondary	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.	30 days
Secondary	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.	60 days
Secondary	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.	90 days
Secondary	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.	120 days
Secondary	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.	150 days
Secondary	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.	180 days
Secondary	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.	30 days
Secondary	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.	60 days
Secondary	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.	90 days
Secondary	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.	120 days
Secondary	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.	150 days
Secondary	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.	180 days
Secondary	Frequency of Elly app use	Frequency of study participant opening the Elly app	180 days
Secondary	Elly app login amount (frequency and duration)	Number of logins to Elly app by study participant	180 days
Secondary	Feasibility	Download of Elly app and engage with app at least 40% 3 or more times over study period.	180 days
Secondary	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.	Day 30
Secondary	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.	Day 360