SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Retention rate among participants enrolled
研究概览
简要总结
This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.
II. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.
OUTLINE: Participants are randomized to 1 of 2 groups.
INTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
- •At time of approach, >= 5 years from initial cancer diagnosis or >= 5 years from first HCT, whichever is later.
- •Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
- •Able to read, write, and speak English.
- •Access to smart phone or computer with internet access.
- •Presence of at least 1 CV risk factor:
- •Currently on medication for hypertension, or
- •Currently on medication for cholesterol or triglyceride, or
- •Currently on medication for diabetes, or
- •Currently not physically active (self-reported average < 30 minutes/day), or
- •Currently smoking.
- •Ability to understand and the willingness to provide informed consent.
排除标准
- •Pre-existing ischemic heart disease (includes angina if documented in electronic medical record [EMR]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).
- •Active systemic treatment for graft versus host disease.
- •Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.
结局指标
主要结局
Retention rate among participants enrolled
时间窗: Up to 1 year
Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention
Enrollment rate among participants approached
时间窗: Up to 1 year
Participation in Healthwatch diet tracking
时间窗: Up to 1 year
Number of participants who provide dietary data on at least 75% of eligible days
Participation in Facebook group
时间窗: Up to 1 year
Number of participants who log onto the group page and participate at least one time (e.g., view a post, post something themselves, respond to a post \[e.g., "like" a post\], etc.)
Participation in Fitbit physical activity tracking
时间窗: Up to 1 year
Number of participants who submit step count data on at least 50% of eligible days
次要结局
未报告次要终点