CancerNCT04604158

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

A study testing Elly Mobile Phone Application in people with Cancer and Cancer Metastatic, run by Gillian Gresham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Cancer Metastatic, Neoplasms
What is being tested?: Elly Mobile Phone Application
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2020to 17 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: IIT2020-13-GRESHAM-ELLY: 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.

Conditions: Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Glioblastoma
Being tested: Elly Mobile Phone Application
Keywords: Elly Health, Elly App
Medical subject headings: Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Lung Neoplasms, Glioblastoma, Prostatic Neoplasms, Colorectal Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elly Mobile Phone ApplicationBehavioural
Also called Elly App
The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.

Study groups in NCT04604158
Study group	Role	What they receive
Elly Mobile Phone Application	Experimental	Not described Receives: Behavioral: Elly Mobile Phone Application

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Secondary outcomes (29)

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.
Measured: 14 days
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 180 days
Frequency of Elly app use
Frequency of study participant opening the Elly app
Measured: 180 days
Elly app login amount (frequency and duration)
Number of logins to Elly app by study participant
Measured: 180 days
Feasibility
Download of Elly app and engage with app at least 40% 3 or more times over study period.
Measured: 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.
Measured: 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.
Measured: Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202017 May 2024

First posted27 Oct 2020
Study start2 Dec 2020
Primary completion17 May 2024
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04604158
Sponsor's protocol ID: IIT2020-13-GRESHAM-ELLY
Status last verified: May 2024
First submitted: 21 Oct 2020
Last updated: 21 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
ClinicalTrials.gov ID: NCT04604158
Acronym / sponsor ID: IIT2020-13-GRESHAM-ELLY
Conditions: Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Glioblastoma
Keywords: Elly Health, Elly App
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Gillian GreshamUniversity, hospital or other
Study start: 2 Dec 2020 (actual)
Primary completion: 17 May 2024 (actual)
Study completion: 17 May 2024 (actual)
First posted: 27 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Elly Mobile Phone Application	Experimental	Behavioral: Elly Mobile Phone Application

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elly Mobile Phone ApplicationAlso: Elly AppThe Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.	Behavioural	Elly Mobile Phone Application

Primary outcome

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.

29 secondary outcomes

Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.
Time frame: 14 days
Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.
Time frame: 60 days
Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.
Time frame: 90 days
Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.
Time frame: 120 days
Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.
Time frame: 150 days
Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.
Time frame: 180 days
Absolute change in patient-reported depression scores at Day 30 compared with baseline.
Time frame: 30 days
Absolute change in patient-reported depression scores at Day 60 compared with baseline.
Time frame: 60 days
Absolute change in patient-reported depression scores at Day 90 compared with baseline.
Time frame: 90 days
Absolute change in patient-reported depression scores at Day 120 compared with baseline.
Time frame: 120 days
Absolute change in patient-reported depression scores at Day 150 compared with baseline.
Time frame: 150 days
Absolute change in patient-reported depression scores at Day 180 compared with baseline.
Time frame: 180 days
Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.
Time frame: 30 days
Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.
Time frame: 60 days
Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.
Time frame: 90 days
Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.
Time frame: 120 days
Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.
Time frame: 150 days
Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.
Time frame: 180 days
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 at Day 60 compared with baseline.
Time frame: 60 days
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 at Day 120 compared with baseline.
Time frame: 120 days
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 at Day 180 compared with baseline.
Time frame: 180 days
Frequency of Elly app use
Time frame: 180 days
Elly app login amount (frequency and duration)
Time frame: 180 days
Feasibility
Time frame: 180 days
Participant's experience with Elly app at Day 14-30.
Time frame: Day 30
Participant's experience with Elly app at Day 180-360.
Time frame: Day 360

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Individual participant dataSharing planned: No

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Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gillian Gresham, PhD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elly Mobile Phone Application in people with Cancer and Cancer Metastatic, run by Gillian Gresham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in patient-reported anxiety scores at Day 30 compared with baseline. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.