Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 21, 2020
First Posted Date  ICMJE October 27, 2020
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE December 2, 2020
Estimated Primary Completion Date July 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Frequency of Elly app use [ Time Frame: 180 days ]
    Frequency of study participant opening the Elly app
  • Elly app login amount [ Time Frame: 180 days ]
    Number of logins to Elly app by study participant
  • Duration of Elly app use [ Time Frame: 180 days ]
    Duration of each Elly app session by study participant
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Official Title  ICMJE IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Elly Mobile Phone Application
Intervention: Behavioral: Elly Mobile Phone Application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 8, 2022
Estimated Primary Completion Date July 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gillian Gresham, PhD 310-423-3341 gillian.gresham@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04604158
Other Study ID Numbers  ICMJE IIT2020-13-GRESHAM-ELLY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gillian Gresham, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Gillian Gresham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gillian Gresham, PhD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP