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

NCT04604158 | Completed DMC

• 1 other identifier: IIT2020-13-GRESHAM-ELLY
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.

  14 days

• Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.

  60 days

• Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.

  90 days

• Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.

  120 days

• Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.

  150 days

Study Arms (1)

Elly Mobile Phone Application

EXPERIMENTAL

Behavioral: Elly Mobile Phone Application

Interventions

Elly Mobile Phone Application BEHAVIORAL

The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.

Also known as: Elly App

Elly Mobile Phone Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Gillian Gresham: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Lung Neoplasms; Glioblastoma; Prostatic Neoplasms; Colorectal Neoplasms; Sarcoma; Kidney Neoplasms; Urinary Bladder Neoplasms; Lymphoma; Leukemia; Head and Neck Neoplasms; Pancreatic Neoplasms; Multiple Myeloma; Anxiety Disorders; Social Isolation; Melanoma; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Mental Disorders; Social Behavior; Behavior; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female

Study Officials

• Gillian Gresham, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: December 2, 2020
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)