ChiCTR1900026244尚未招募早期 1 期
Breast Cancer App protocol: a randomized controlled trial to evaluate a self-management app for breast cancer survivors
Departmental research fund1 个研究点 分布在 1 个国家目标入组 488 人开始时间: 2020年1月1日最近更新:
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Problem solving skills-The Social Problem-Solving Inventory Revised-Short Form (SPSI-R: S)
研究概览
简要总结
- to examine whether there is the difference in the health literacy, problem solving skills, readiness of change, self-efficacy, self-management skill, and health-related quality of life between the intervention group and the control group;
- to examine the usability of this self-management app versus a general health app.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- Female
入选标准
- •breast cancer survivors;
- •Cancer stages I to III;
- •completion of primary treatment within one year or longer;
- •aged 18 to 65 years;
- •acceptable literacy level (e.g. able to read, and write Chinese);
- •agree for checking of usage log of mobile app;
- •able to provide informed consent.
排除标准
- •BCS diagnosed with severe mental illnesses;
- •Diagnosis of another cancer type rather than breast cancer;
- •has already participated in other clinical trial;
- •has been used other self-management app to manage the breast cancer.
研究组 & 干预措施
Experimental group
Mobile application-'Be with You' App
Control group
Mobile application- 'Sham' App
结局指标
主要结局
Problem solving skills-The Social Problem-Solving Inventory Revised-Short Form (SPSI-R: S)
时间窗: Baseline, week 4, week 12
Self management-A Morisky Medication Adherence Scale 8 (MMAS-8)
时间窗: Baseline, week 4, week 12
Self-efficacy-The Self-Efficacy to Manage Chronic Disease Scale (SEMCD)
时间窗: Baseline, week 4, week 12
次要结局
- Health literacy level-Brief Health Literacy Screening (BHLS)(Baseline, week 4, week 12)
- Health-related Quality of life (HRQOL)-12-item Short-Form Health Survey (SF-12)(Baseline, week 4, week 12)
- Readiness of change-The University of Rhode Island Change Assessment Scale (URICA)(Baseline, week 4, week 12)
- Usability of app(week 4, week 12)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1/2 期
smartphone application in cancer screening follow-upCTRI/2024/04/066328AIIMS132
Enrolling By Invitation
不适用
Gagne Learning Model in Nursing EducationNCT07348549Namik Kemal University68
已完成
不适用
Understanding Health Knowledge in Parents of Children with Cancer.CTRI/2024/12/078286Kota Nithyusha422
招募中
不适用
Evaluation of the Effectiveness of Health Literacy Education Given to Women by Teach-Back MethodNCT07320079Istanbul University - Cerrahpasa74
尚未招募
不适用
Effect of Mind Body Medicine Program in Young Female Breast Cancer patients on sleep quality, quality of life and physiological and biochemical parametersCTRI/2024/11/076635CCRYN108