Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
RESTORE
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
1 other identifier
interventional
352
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Mar 2022
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedOctober 25, 2022
October 1, 2022
9 months
January 6, 2022
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline up to week 12
Secondary Outcomes (15)
Symptoms of depression
Baseline up to week 12
Symptoms of emotional distress
Baseline up to week 12
Positive and negative affect
Baseline up to week 12
Cancer-related symptoms of anxiety (thought intrusions)
Baseline up to week 12
Wellbeing and quality of life
Baseline up to Week 12
- +10 more secondary outcomes
Other Outcomes (1)
Healthcare utilization
Baseline up to Week 12
Study Arms (2)
Attune™
ACTIVE COMPARATORAttune™ is a completely digital therapeutic intervention.
Cerena™
ACTIVE COMPARATORCerena™ is a completely digital therapeutic intervention.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Blue Note Therapeuticslead
- Curebase Inc.collaborator
Study Sites (1)
Www.Restoreclinicaltrial.Com
San Francisco, California, 94104, United States
Related Publications (2)
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.
PMID: 39621368DERIVEDZion 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.
PMID: 37862670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dianne M Shumay
Blue Note Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2022
First Posted
February 8, 2022
Study Start
March 10, 2022
Primary Completion
December 2, 2022
Study Completion
December 15, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10