Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer

Blue Note Therapeutics352 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

352

Conditions

Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline up to week 12

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).