Clinical trial NCT05227898: Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Breast Cancer
Colon/Rectal Cancer
Endometrial Cancer
Lymphoma
Leukemia
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Thyroid Cancer
Lead sponsor: Blue Note Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Curebase Inc.
First posted: 2022-02-08
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Symptoms of anxiety
timeFrame: Baseline up to week 12
Secondary outcomes:
measure: Symptoms of depression
timeFrame: Baseline up to week 12
measure: Symptoms of emotional distress
timeFrame: Baseline up to week 12
measure: Positive and negative affect
timeFrame: Baseline up to week 12
measure: Cancer-related symptoms of anxiety (thought intrusions)
timeFrame: Baseline up to week 12
measure: Wellbeing and quality of life
timeFrame: Baseline up to Week 12
measure: Global Improvement-Likert Scale
timeFrame: Baseline up to Week 12
measure: Symptom-related distress
timeFrame: Baseline up to week 12
measure: Perceived stress
timeFrame: Baseline up to Week 12
measure: Level of stress management skill and coping skill efficacy (PAM)
timeFrame: Baseline up to Week 12
measure: Level of stress management skill and coping skill efficacy (MOCS Part A)
timeFrame: Baseline up to Week 12
measure: Non-specific (social) intervention effects
timeFrame: Baseline up to Week 12
measure: Benefit Finding
timeFrame: Baseline up to Week 12
measure: Safety of each digital product
timeFrame: Baseline up to Week 12
measure: Usability of each digital product
timeFrame: Week 12
measure: Acceptability of each digital product
timeFrame: Week 12
Other outcomes:
measure: Healthcare utilization
timeFrame: Baseline up to Week 12
Locations:
city: San Francisco
country: United States
facility: Www.Restoreclinicaltrial.Com
state: California
Study officials:
affiliation: Blue Note Therapeutics
name: Dianne M Shumay
role: PRINCIPAL_INVESTIGATOR
References: