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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Symptoms of anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Symptoms of anxiety
时间窗: 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).
次要结局
- Symptom-related distress(Baseline up to week 12)
- Safety of each digital product(Baseline up to Week 12)
- Global Improvement-Likert Scale(Baseline up to Week 12)
- Symptoms of depression(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)
- Perceived stress(Baseline up to Week 12)
- Level of stress management skill and coping skill efficacy (PAM)(Baseline up to Week 12)
- Acceptability of each digital product(Week 12)
- Symptoms of emotional distress(Baseline up to week 12)
- Non-specific (social) intervention effects(Baseline up to Week 12)
- Benefit Finding(Baseline up to Week 12)
- Level of stress management skill and coping skill efficacy (MOCS Part A)(Baseline up to Week 12)
- Usability of each digital product(Week 12)