Developing and Examining Preliminary Effects of An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery (iCareBreast): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Participant's self-efficacy
研究概览
简要总结
This study aims to develop a mobile app-based periopeartive intervnetion for women undergoing breast cancer surgery and examine the effectiveness of the program on participants' health outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care. This study also aims to explore the perceptions of participants on strengths and weaknesses of using the app.
详细描述
Background: Breast cancer is the most common cancer in women worldwide and Singapore. In addition to the disease itself, undergoing surgery is also a stressful event for patients. Many of them have physical and psychosocial challenges. A variety of psychosocial interventions have been developed to improve patients'/survivors' health outcomes with some intervention using mobile technology. However, there is no any smart-phone based solution that have developed a comprehensive perioperative solution for this group of patients.
Aim: This study aims to (1) develop an Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery (iCareBreast); (2) examine the effectiveness of the iCareBreast on participants' health outcomes of self-efficacy (primary outcome), anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care; and (3) explore the perceptions of participants on strengths and weaknesses of iCareBreast.
Research Questions:
- Do the participants receiving routine care plus the iCareBreast report higher level of self-efficacy when compared to those receiving routine care alone?
- Do the participants receiving routine care plus the iCareBreast report lower levels of anxiety and depression when compared to those receiving routine care alone?
- Do the participants receiving routine care plus the iCareBreast report lower levels of postoperative pain and fatigue when compared to those in the control group?
- Do the participants receiving routine care plus the iCareBreast report higher level of quality of life when compared to those receiving routine care alone?
- Do the participants receiving routine care plus the iCareBreast report higher level of satisfaction with perioperative care when compared to those receiving routine care alone?
- What are the perceptions of participants on strengths and weaknesses of iCareBreast?
Hypothesis As compared to the participants in the control group, those in the intervention group who receive routine care plus the iCareBreast will report a
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The principal investigator will generate the randomisation number and randomisation sequences according to the block randomisation method. The randomly generated sequences would be used for recruitment of the participants, who will be assigned in successive order according to the sequence. Opaque and sealed envelopes containing slips of paper indicate the randomly allocated group. One research assistant will recruit participants and conduct randomisation and another research assistant who is blind from the group allocation will collect post-test data. Through these carefully deliberated processes, randomization and allocation concealment will be ensured.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •are the age of 21 years old and above at the point of recruitment;
- •are diagnosed with breast cancer;
- •will undergo breast cancer surgery (mastectomy or wide excision);
- •can speak, read and write in English; and
- •has access to smart phone.
排除标准
- •been suffering from psychiatric illness or impaired cognitive function;
- •alcohol or substance abuse within the previous year;
- •anxiety disorder and other mood disorder as identified from their medical records; and
- •been in the bereavement period in the last 6 months.
结局指标
主要结局
Participant's self-efficacy
时间窗: Participant's self-efficacy will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.
Participant's self-efficacy level will be measured using the 10-item General Self-Efficacy (GSE) Scale. The total score for GSE is tabulated by the sum of all scores of each component. The scoring system ranges between 10 and 40. The higher the score achieved, the higher the level of self-efficacy (Schwarzer \& Jerusalem, 1995).
次要结局
- Process evaluation interview(Semi-structured interviews will be conducted around 2 weeks after surgery.)
- Participant's anxiety and depression(Participant's anxiety and depression will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.)
- Participant's pain and fatigue(Participant's pain and fatigue will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.)
- Participant's quality of life(Participant's quality of life will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.)
- Satisfaction with perioperative care(Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.)
研究者
HE Hong-Gu
Associate Professor
National University of Singapore