The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Calgary Symptoms of Stress Inventory (C-SOSI)
研究概览
简要总结
There is a need to develop, evaluate, and disseminate self-directed, easily accessible, safe, affordable, and effective psychosocial interventions to people living with cancer (PLWC) post-treatment. Smartphone app-based health interventions are an innovative way to deliver psychosocial cancer-care. The Mindfulness-Based Cancer Survivorship (MBCS) Journey app is a mobile app format of the Mindfulness-based Cancer Recovery program. In the SEAMLESS Study, the investigators aim to evaluate the MBCS Journey app (a 4 week mind-body intervention) in cancer survivors post-treatment. This is a randomized wait-list controlled trial. Participants will either be assigned into the immediate group (will receive intervention immediately after enrollment) or the waitlist group (wait for 3 months before receiving the intervention).
详细描述
BACKGROUND: Cancer patients who are transitioning into the survivorship phase after completing their final treatments often have unmet needs that are different than those faced during the diagnosing phase or treatment phase of their journey. PLWC tend to experience late and long-term effects such as pain, fatigue, and distress. They can also experience psychosocial stressors such as anxiety, depression, uncertainty about the future, and the fear of cancer reoccurrence, which can negatively impact their mental health.
Cancer survivors are often unable to receive the face-to-face care they need due to barriers such as compromised immunity, treatment-related side effects, scheduling conflicts, and geography. Having a smartphone app-based mind-body intervention can help patients overcome several of these barriers since they are able to participate in at their own convenience in the comfort of their own home without the burden of travelling to and scheduling these classes.
INTERVENTION DESIGN: The AM smartphone app (where MBCS Journey can be found) supports personalized mindfulness practices through lessons and personalized guided-meditation playlists. The AM app is able to interpret its users' emotional state e.g. angry, elated. from a user-inputted digital emotion-mapping board; and heart-rate data through algorithms that analyze facial bio-signals. The SEAMLESS study aims to evaluate AM's effectiveness for reducing stress (primary outcome), anxiety, depression, fatigue, and overall physical functioning and quality of life (secondary outcome) as well as determining the mechanisms of action. In addition, there are two exploratory objectives: 1) to explore the sex, and gender-based differences in significant outcomes as well as subgroup effects by cancer stage, type, ethnicity, and age and 2) explore the correlation between self-reported stress reduction and app usage and the correlation between stress ratings and psycho-biometric data collected within the app. Outcomes will be assessed using validated Calgary Symptoms of Stress Inventory (for stress), the PROMIS measure (for anxiety, depression, fatigue, and overall physical functioning), and the European Organization for Research and Treatment of Cancer quality of life questionnaire (for quality of life). Assessments will occur at 1) baseline, 2) post-intervention, 3) 3 month after baseline follow-up, and 4) 6 month post-intervention follow-up.
SIGNIFICANCE: In today's digital world, there are many app-based interventions for patients but cancer-care providers are uncertain about their efficacy. Our study will provide rigorously evaluated efficacy data for a smartphone app-based mind-body intervention for cancer survivors, which if helpful, could be made easily available for psychosocial care at cancer centers worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adult ≥ 18 years
- •Diagnosed with any type of cancer (stages I-IV)
- •Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary.
- •Have access to a smartphone with data or wifi connection.
- •Willing to devote 20-30 mins of time to mindfulness practices daily during the 4-week intervention period.
- •Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form (e-consent) prior to enrollment in the study to document their willingness to participate.
- •Participant is able (i.e. sufficiently fluent) and willing to complete the MBCS Journey and outcome measures in either English or French. The baseline assessment must be completed within required timelines, prior to randomization.
- •In accordance with CCTG policy, protocol intervention is intended to begin within 7 calendar days of patient randomization.
- •Participants must be willing to complete the MBCS Journey and complete the follow-up questionnaires
排除标准
- •Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or cognitive impairment (score of ≤ 6; as assessed by the centre CRA using the three questions from the Brief Screen for Cognitive Impairment (BSCI)) listed in the screening CRF, which could interfere with completing the intervention and/or the questionnaires (i.e. inability to read or write)
- •Suffering from untreated Major Depressive Disorder or other psychiatric disorders that would interfere with participation. (Note: Participants will be referred for treatment and invited to call back once in remission).
- •Previous experience practicing in-person or app-based mindfulness once a week or more within the last year.
研究组 & 干预措施
Immediate Mindfulness
A 4 week smartphone app-based mindfulness intervention program with in-app activities for 20-30 minutes everyday, with a minimum of 4 days of activity in a week.
干预措施: Mindfulness (Behavioral)
Control Mindfulness
No intervention and usual care for 4 weeks, after which there will be assessments immediately post-waiting and at 3 months post-baseline. After this, participants will get the same 4 week smartphone app-based mindfulness intervention program.
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Calgary Symptoms of Stress Inventory (C-SOSI)
时间窗: 3 months
This is a 56 item scale. Each item is rated on a 5-point Likert scale (1-5). A higher score indicates higher levels of stress.
次要结局
- Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function(3 months)
- Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue(3 months)
- App-based User Data - Mood(3 months)
- Quality of Life - European Organization for Research and Treatment of Cancer quality of life(3 months)
- App-based User Data - Perceived Stress(3 months)
- Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety(3 months)
- Patient Reported Outcome Measurement Information System (PROMIS) - Depression(3 months)
- App-based User Data - Objective Stress(3 months)
- Total symptoms of stress from the C-SOSI to determine the impact of the one-month MBCS Journey intervention on stress immediately after the therapeutic intervention at one month from randomization(1 month after randomization)