Anatomic Stage I Breast Cancer AJCC v8NCT04862195
Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
A study testing Attune™ and Cerena™ in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Blue Note Therapeutics at 13 sites in United States.
Trial summary
This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Attune™ and Cerena™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 13 sitesUnited States
- Study dates
- 15 May 2021to 1 Sep 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
- Are experiencing at least moderate anxiety (GAD-7 >10) or mild-to-moderate depression (PHQ-8 score 5-11);
- Are fluent in English; and
- Have access to smartphone, or tablet capable of running iOS or Android software.
Who cannot join
- Previous history of cancer;
- <2-yr survival prognosis as determined by treating clinician;
- Currently participating in investigative CBT trial for treatment of anxiety or depression;
- Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study;
- Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics-sponsored study; and
- PHQ-9 Q9 response >0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Rogel Cancer Center | University of Michigan
Ann Arbor, Michigan, 48109-0944
SCL Health
Billings, Montana, 59102
Massachusetts General Hospital
Boston, Massachusetts, 02114
New Jersey Center for Cancer Research
Brick, New Jersey, 08724
OPN Healthcare
Glendale, California, 91203
MD Anderson
Houston, Texas, 77030
Oncology Physicians Network Healthcare
Los Alamitos, California, 90720
Tri-County Hematology and Oncology-Massillon
Massillon, Ohio, 44646
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, 06360
Illinios Cancer Care
Peoria, Illinois, 61615-7828
New York Cancer & Blood Specialists
Port Jefferson Station, New York, 11776
Redlands Oncology
Redlands, California, 92373
Northwest Medical Specialty
Tacoma, Washington, 98405
About this study
Official title: Double-blinded, Randomized, Adaptive Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices (Attune™ and Cerena™) as Interventions for Physical and Emotional Health in Adjunctive Oncology Treatment
This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks.
Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12.
An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Being tested
- Attune™, Cerena™
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attune™Device
Software as a medical device
Cerena™Device
Software as a medical device
| Study group | Role | What they receive |
|---|---|---|
| Attune™ | Active comparator | Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention. Receives: Device: Attune™ |
| Cerena™ | Active comparator | Cerena™ is a completely digital, 10-session, health education and wellness intervention. Receives: Device: Cerena™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related symptoms of anxiety (1)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Measured: Baseline up to Week 10
Secondary outcomes (5)
Cancer-related symptoms of depression (1)
Percent reduction in PROMIS-D scores, reduction indicates reduced depression
Measured: Baseline up to Week 10
Cancer-related symptoms of anxiety (2)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Measured: Baseline up to Week 12
Cancer-related symptoms of anxiety (3)
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety
Measured: Baseline up to Week 10
Cancer-related symptoms of depression (4)
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression
Measured: Baseline up to Week 12
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Higher scores indicate higher ease of use / easier to use applications
Measured: Baseline up to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 May 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: This study was halted prematurely due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Note Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia A Ganz, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862195
- Sponsor's protocol ID
- PROT001
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded, Randomized, Adaptive Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices (Attune™ and Cerena™) as Interventions for Physical and Emotional Health in Adjunctive Oncology Treatment
- ClinicalTrials.gov ID
- NCT04862195
- Acronym / sponsor ID
- PROT001
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was halted prematurely due to slow enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Blue Note TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 27 Apr 2021 (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.
This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks.
Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12.
An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attune™ | Active comparator | Device: Attune™Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention. |
| Cerena™ | Active comparator | Device: Cerena™Cerena™ is a completely digital, 10-session, health education and wellness intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
- Are experiencing at least moderate anxiety (GAD-7 >10) or mild-to-moderate depression (PHQ-8 score 5-11);
- Are fluent in English; and
- Have access to smartphone, or tablet capable of running iOS or Android software.
Key exclusion criteria (6 listed)
- Previous history of cancer;
- <2-yr survival prognosis as determined by treating clinician;
- Currently participating in investigative CBT trial for treatment of anxiety or depression;
- Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study;
- Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics-sponsored study; and
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 |
|---|---|---|
| Attune™Software as a medical device | Device | Attune™ |
| Cerena™Software as a medical device | Device | Cerena™ |
Primary outcome
Cancer-related symptoms of anxiety (1)
Time frame: Baseline up to Week 10
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
5 secondary outcomes
Cancer-related symptoms of depression (1)
Time frame: Baseline up to Week 10
Cancer-related symptoms of anxiety (2)
Time frame: Baseline up to Week 12
Cancer-related symptoms of anxiety (3)
Time frame: Baseline up to Week 10
Cancer-related symptoms of depression (4)
Time frame: Baseline up to Week 12
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Time frame: Baseline up to Week 10
Results and safety
The study was stopped early (reason given: This study was halted prematurely due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Patricia A Ganz, MD principal investigator
University of California, Los Angeles
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attune™ and Cerena™ in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Blue Note Therapeutics at 13 sites 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 was stopped early (reason given: This study was halted prematurely due to slow enrollment). Results are not available in the source record.
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?
Cancer-related symptoms of anxiety (1) (time frame: Baseline up to Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2022.