CancerRESTORENCT05227898
Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
A study testing Device: Attune™ and Device: Cerena™ in people with Cancer, run by Blue Note Therapeutics at 1 site in United States.
Trial summary
This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Device: Attune™ and Device: Cerena™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 15 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III cancer diagnosis
- Currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment.
- Are experiencing at least moderate anxiety
- 18 years of age or older
- Are fluent in English
- Have access to a smartphone (a mobile phone that performs many of the functions of a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications) or tablet that runs iOS or Android software, with cellular data service or wifi access.
- Willing to download software onto smartphone or tablet from Apple store or Android store
Who cannot join
- Systemic treatment plan includes only endocrine therapy.
- Treatment plan includes stem cell/bone marrow transplant.
- Currently participating in any other 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 device or Blue Note Therapeutics-sponsored study
- Are experiencing severe levels of depression OR indicate suicidal risk (measured by surveys during screening for the study)
- Are experiencing anxiety below the required level (measured by a survey during screening for the study)
- Cancer diagnosis is melanoma, multiple myeloma, unstaged cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Www.Restoreclinicaltrial.Com
San Francisco, California, 94104
About this study
Official title: Two-arm, Double-blind, Randomized Controlled Trial to Compare Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Patients With Stage I-III Cancer
This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.
The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.
- Conditions
- Cancer
- Being tested
- Device: Attune™, Device: Cerena™
- Keywords
- Breast Cancer, Colon/Rectal Cancer, Endometrial Cancer, Lymphoma, Leukemia, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Thyroid Cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Lymphoma, Leukemia, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Attune™Device
People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.
Device: Cerena™Device
People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities.
| Study group | Role | What they receive |
|---|---|---|
| Attune™ | Active comparator | Attune™ is a completely digital therapeutic intervention. Receives: Device: Device: Attune™ |
| Cerena™ | Active comparator | Cerena™ is a completely digital therapeutic intervention. Receives: Device: Device: Cerena™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety
The PROMIS-Anxiety (PROMIS-A) is a validated PRO consisting of 8 questions measuring anxiety symptoms. The change in PROMIS-A score over time will be assessed (reduction indicates reduced anxiety).
Measured: Baseline up to week 12
Secondary outcomes (15)
Symptoms of depression
The PROMIS-Depression (PROMIS-D) is a validated PRO consisting of 8 questions measuring depression symptoms. The change in PROMIS-D score over time will be assessed (decrease indicates reduced depression).
Measured: Baseline up to week 12
Symptoms of emotional distress
Change in PROMIS Emotional Distress; a composite of PROMIS-Anxiety and PROMIS-Depression over time (decrease indicates reduced emotional distress).
Measured: Baseline up to week 12
Positive and negative affect
The Positive and Negative Affect Schedule Short Form (PANAS-SF) measures positive and negative affect. Change in PANAS-SF scores over time will be assessed (increase in Positive Affect Scale indicates increase in positive emotions and expression; decrease in Negative Affect Scale indicates decrease in negative emotions and expression).
Measured: Baseline up to week 12
Cancer-related symptoms of anxiety (thought intrusions)
The Impact of Events Scale-Revised (IES-R) is used to assess subjective distress caused by a stressful life event. The change in the IES-R Intrusion subscale mean score over time will be assessed (decrease in Intrusion score indicates reduced intrusive symptoms related to a specific stressor).
Measured: Baseline up to week 12
Wellbeing and quality of life
The Functional Assessment of Cancer Therapy - General (FACT-G) is designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The change in FACT-G scores over time will be assessed (a reduction in the FACT-G total score, derived from the subscale scores, indicates an increased health-related quality of life).
Measured: Baseline up to Week 12
Global Improvement-Likert Scale
The Global Improvement-Likert Scale uses a Likert scale to assess participant self-perception of the level of improvement of their overall well-being, symptoms of anxiety, and symptoms of depression since they began the study.
Measured: Baseline up to Week 12
Symptom-related distress
The Rotterdam Symptom Checklist (RSCL) is measures health-related quality of life of cancer patients. This study uses the same Likert scale and a subset of the symptoms ("eye strain" and "headache") that are part of the Rotterdam Symptom Checklist with the addition of the symptom "finger cramping" to monitor for all potential device adverse effects.
Measured: Baseline up to week 12
Perceived stress
The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. The change in PSS scores over time will be assessed (higher PSS scores indicate higher perceived stress).
Measured: Baseline up to Week 12
Level of stress management skill and coping skill efficacy (PAM)
The Patient Activation Measure (PAM) is used to assess the knowledge, skills, and confidence to manage one's health. The change in PAM scores over time will be assessed (higher PAM scores indicate higher patient activation).
Measured: Baseline up to Week 12
Level of stress management skill and coping skill efficacy (MOCS Part A)
The Measure of Current Status (MOCS) Part A measures self-perceived status for using coping skills. The change in MOCS Part A scores over time will be assessed (increase indicates greater confidence in skill use ability).
Measured: Baseline up to Week 12
Non-specific (social) intervention effects
The Measure of Current Status (MOCS) Part B assesses non-specific intervention effects - feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. The change in MOCS Part B scores over time will be assessed (increase indicates greater non-specific intervention effects).
Measured: Baseline up to Week 12
Benefit Finding
The Benefit Finding Scale (BFS) assesses the perception that positive contributions were made to one's life by the experience of being diagnosed with and treated for cancer. The change in BFS scores over time will be assessed
Measured: Baseline up to Week 12
Safety of each digital product
Self-reported device related adverse events; 3-item Distress Assessment and Response Tool (DART) self-reported to monitor suicidality.
Measured: Baseline up to Week 12
Usability of each digital product
mHealth App Usability Questionnaire (MAUQ) mean scores will be measured at end of study (higher scores indicate higher ease of use / easier to use applications).
Measured: Week 12
Acceptability of each digital product
Net promoter score (NPS), an index ranging from -100 to 100 that measures willingness to recommend the digital products, will be measured at end of study.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Mar 2022
- Primary completion2 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Note Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Dianne M Shumay, Principal investigator, Blue Note Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227898
- Sponsor's protocol ID
- PROT004
- Acronym
- RESTORE
- Status last verified
- Oct 2022
- First submitted
- 6 Jan 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Taub CJ, Zion SR, Ream M, Ramiller A, Heathcote LC, Eich G, Mendelsohn M, Birckbichler J, Ganz PA, Cella D, Penedo FJ, Antoni M, Shumay DM. Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial. J Consult Clin Psychol. 2024 Nov;92(11):727-741. doi: 10.1037/ccp0000911.
PubMed 39621368Zion SR, Taub CJ, Heathcote LC, Ramiller A, Tinianov S, McKinley M, Eich G, Penedo FJ, Ganz PA, Antoni M, Shumay DM. Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1179-1189. doi: 10.1200/OP.23.00210. Epub 2023 Oct 20.
PubMed 37862670
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-arm, Double-blind, Randomized Controlled Trial to Compare Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Patients With Stage I-III Cancer
- ClinicalTrials.gov ID
- NCT05227898
- Acronym / sponsor ID
- RESTORE / PROT004
- Conditions
- Cancer
- Keywords
- Breast Cancer, Colon/Rectal Cancer, Endometrial Cancer, Lymphoma, Leukemia, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Blue Note TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 2 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 8 Feb 2022 (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 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site.
The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.
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: Device: Attune™Attune™ is a completely digital therapeutic intervention. |
| Cerena™ | Active comparator | Device: Device: Cerena™Cerena™ is a completely digital therapeutic intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage I-III cancer diagnosis
- Currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment.
- Are experiencing at least moderate anxiety
- 18 years of age or older
- Are fluent in English
Key exclusion criteria (8 listed)
- Systemic treatment plan includes only endocrine therapy.
- Treatment plan includes stem cell/bone marrow transplant.
- Currently participating in any other 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 device or Blue Note Therapeutics-sponsored study
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 |
|---|---|---|
| Device: Attune™People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities. | Device | Attune™ |
| Device: Cerena™People enrolled in the study use the app to complete ten informational sessions, each approximately 60-minute in length. The app also include guided exercises and other interactive opportunities. | Device | Cerena™ |
Primary outcome
Symptoms of anxiety
Time frame: Baseline up to week 12
The PROMIS-Anxiety (PROMIS-A) is a validated PRO consisting of 8 questions measuring anxiety symptoms. The change in PROMIS-A score over time will be assessed (reduction indicates reduced anxiety).
15 secondary outcomes
Symptoms of depression
Time frame: Baseline up to week 12
Symptoms of emotional distress
Time frame: Baseline up to week 12
Positive and negative affect
Time frame: Baseline up to week 12
Cancer-related symptoms of anxiety (thought intrusions)
Time frame: Baseline up to week 12
Wellbeing and quality of life
Time frame: Baseline up to Week 12
Global Improvement-Likert Scale
Time frame: Baseline up to Week 12
Symptom-related distress
Time frame: Baseline up to week 12
Perceived stress
Time frame: Baseline up to Week 12
Level of stress management skill and coping skill efficacy (PAM)
Time frame: Baseline up to Week 12
Level of stress management skill and coping skill efficacy (MOCS Part A)
Time frame: Baseline up to Week 12
Non-specific (social) intervention effects
Time frame: Baseline up to Week 12
Benefit Finding
Time frame: Baseline up to Week 12
Safety of each digital product
Time frame: Baseline up to Week 12
Usability of each digital product
Time frame: Week 12
Acceptability of each digital product
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 39621368Taub CJ, Zion SR, Ream M, Ramiller A, Heathcote LC, Eich G, Mendelsohn M, Birckbichler J, Ganz PA, Cella D, Penedo FJ, Antoni M, Shumay DM. Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial. J Consult Clin Psychol. 2024 Nov;92(11):727-741. doi: 10.1037/ccp0000911.
- Derived from this study: PubMed 37862670Zion SR, Taub CJ, Heathcote LC, Ramiller A, Tinianov S, McKinley M, Eich G, Penedo FJ, Ganz PA, Antoni M, Shumay DM. Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1179-1189. doi: 10.1200/OP.23.00210. Epub 2023 Oct 20.
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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.
Dianne M Shumay principal investigator
Blue Note Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Attune™ and Device: Cerena™ in people with Cancer, run by Blue Note Therapeutics 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Oct 2022. 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?
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?
Symptoms of anxiety (time frame: Baseline up to week 12). 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 NCT05227898, which also lists 2 linked publications.
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 25 Oct 2022.