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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elly Mobile Phone Application | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elly Mobile Phone Application | Behavioral | The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Gillian Gresham, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Frequency of Elly app use | Frequency of study participant opening the Elly app | 180 days |
| Elly app login amount (frequency and duration) | Number of logins to Elly app by study participant | 180 days |
| Feasibility | Download of Elly app and engage with app at least 40% 3 or more times over study period. | 180 days |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D005909 | Glioblastoma |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012509 | Sarcoma |
| D007680 | Kidney Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D006258 | Head and Neck Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D009101 | Multiple Myeloma |
| D001008 | Anxiety Disorders |
| D012934 | Social Isolation |
| D008545 | Melanoma |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D001745 | Urinary Bladder Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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