Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of BNT001, a Digital Cognitive-Behavioral Stress Management (CBSM) Software Application for Treatment of Anxiety and Depressive Symptoms in Veterans With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To measure changes in pre and post cancer-related distress in patient participants.
研究概览
简要总结
This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
详细描述
This pilot will study specific implementation barriers and facilitators, procedures that are necessary to ensure adherence to utilization of the digital program, as well as any potential safety issues associated with recruiting and offering an intervention to cancer patients with moderate anxiety or mild depressive symptoms. Data relating to patient experience, adherence, satisfaction and pre-post intervention outcomes will also be tracked.
The study will run in two distinct phases to first assess the process of clinical implementation by prescribing oncology clinicians, and in a second more expanded phase, further assess the clinical implementation and impact on enrolled patients.
Study Phase 1: We aim to identify promoters and barriers to the clinical implementation of BNT001, a software application that delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Study Phase 2: We aim to further identify promoters and barriers to provider clinical implementation of BNT001, assess patient acceptability and feasibility including patient adherence to BNT's 10-sessions, and obtain preliminary data on BNT001's impact on cancer-related distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis or history of invasive cancer (excluding non-melanoma skin cancer).
- •Patients showing mild to moderate anxiety or depression on the Veteran System Assessment Screen (VSAS), with anxiety or depression scored as 1-6 on a 0-10 scale.
- •Fluent in English.
- •Has access to iOS or Android smartphone, or tablet and capable of receiving text messages.
- •Has an e-mail address.
排除标准
- •Endorses thoughts of self-harm, history of suicidality.
- •Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression.
- •Participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; 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 sponsored study.
结局指标
主要结局
To measure changes in pre and post cancer-related distress in patient participants.
时间窗: Baseline to 12 weeks
Patient participants symptoms will be assessed with the Veterans Symptom Assessment Screen (VSAS). The VSAS is a clinical patient reported outcomes tool to document cancer-related symptoms to improve quality of life that has been adopted across VA hematology-oncology sites. The VSAS is comprised of 13 symptoms, rated on a 0 to 10 scale.
Identification of promoters and barriers to clinical implementation
时间窗: Baseline to 4 weeks
Identification of promoters and barriers to clinical implementation of BNT001, a software application that delivers a 10-session, cancer-specific, behavioral intervention called Cognitive-Behavioral Stress Management (CBSM), to adult patients currently undergoing cancer treatment.
次要结局
- Patient completion rates(Baseline to 12 weeks)
- Patient feasibility and acceptability(Baseline to 12 weeks)