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

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ClinicalTrials.gov Identifier: NCT04604158
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Gillian Gresham, Cedars-Sinai Medical Center

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 Not Applicable

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Study Type : Interventional
Estimated 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 : December 2, 2020
Estimated Primary Completion Date : July 8, 2022
Estimated Study Completion Date : July 8, 2022


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 Name: Elly App




Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: 180 days ]
    Number of logins to Elly app by study participant

  27. Duration of Elly app use [ Time Frame: 180 days ]
    Duration of each Elly app session by study participant

  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604158


Contacts
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Contact: Gillian Gresham, PhD 310-423-3341 gillian.gresham@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Gillian Gresham    310-423-3341    gillian.gresham@cshs.org   
Principal Investigator: Gillian Gresham, PhD         
Sponsors and Collaborators
Gillian Gresham
Investigators
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Principal Investigator: Gillian Gresham, PhD Cedars-Sinai Medical Center
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Responsible Party: Gillian Gresham, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04604158    
Other Study ID Numbers: IIT2020-13-GRESHAM-ELLY
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gillian Gresham, Cedars-Sinai Medical Center:
Elly Health
Elly App
Additional relevant MeSH terms:
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Glioma
Multiple Myeloma
Glioblastoma
Kidney Neoplasms
Pancreatic Neoplasms
Uterine Neoplasms
Anxiety Disorders
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Mental Disorders
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Astrocytoma
Neoplasms, Neuroepithelial