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NCT Number: NCT04604158

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.

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Key information

Conditions

Cancer Anxiety Anxiety Disorders Astrocytoma Behavior Bladder Cancer Blood Protein Disorders Breast Cancer Breast Diseases Breast Neoplasms Cancer Metastatic Cardiovascular Diseases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioma Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Loneliness Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Mental Disorders Multiple Myeloma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Social Behavior Social Isolation Stress Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elly Mobile Phone Application

Behavioral

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

Other names: Elly App

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. Frequency of Elly app use

    Time frame: 180 days

    Frequency of study participant opening the Elly app

  26. Elly app login amount (frequency and duration)

    Time frame: 180 days

    Number of logins to Elly app by study participant

  27. Feasibility

    Time frame: 180 days

    Download of Elly app and engage with app at least 40% 3 or more times over study period.

  28. 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.

  29. 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.

Sponsors and collaborators

Lead sponsor

Gillian Gresham

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2020
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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