The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- decisional conflict
研究概览
简要总结
This study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality in women with breast cancer undergoing mastectomy and considering immediate breast reconstruction. Half of participants will receive care as usual and access to the online decision aid, while the other half will receive care as usual including a standard information leaflet.
详细描述
Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with breast cancer each year, about 40% undergo mastectomy. A wide variety of breast reconstructive methods are offered to these women. In most cases, there is no clear medical recommendation on which procedure is the best. Decisions for breast surgery and reconstruction are frequently made during an emotionally burdensome and restricted timeframe. Women may find it hard to make a decision for the type of surgery and reconstruction, some feel that the decision is hurried and uninformed, and many have some degree of regret about their decision at a later date. To support women in making a well-informed decision about breast reconstruction, an online patient decision aid (pDA) has been developed.
Objective
The primary objective of the study is to evaluate the impact of the use of the online pDA on the process of decision making regarding breast reconstruction and the decision quality. The secondary objective of the study is to evaluate the impact of the use of the online pDA on patient reported health outcomes, to identify possible moderators of the effect, and to investigate the cost-effectiveness.
Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve the decision making process about breast reconstruction (i.e. leads to less decisional conflict, higher satisfaction with information, higher levels of preparedness for decision making and higher perceived levels of shared decision making) and that it will improve the decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and lower levels of regret).
Study design: A multicenter randomized controlled trial (RCT) will be performed in eight hospitals. All consenting participants will be randomized into one of the two study arms (intervention group or control group). Women in both groups will be invited to complete questionnaires at baseline (i.e. before randomization), 1 week after consultation with a plastic surgeon and 3 and 12 months after breast surgery.
Study population: 250 women will participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female (≥18 years);
- •diagnosed with breast cancer or carcinoma in situ;
- •will be treated with mastectomy and is eligible for immediate breast reconstruction;
- •is referred to a plastic surgeon (consultation takes place ≥3 working days after study invitation);
- •has internet access and sufficient computer skills;
- •is able to read and speak the Dutch language.
排除标准
- 未提供
研究组 & 干预措施
control group
Care as usual with a standard information leaflet
intervention group
Care as usual and an online patient decision aid
干预措施: online patient decision aid (Other)
结局指标
主要结局
decisional conflict
时间窗: 1 week after consultation with a plastic surgeon (T1)
decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.
次要结局
- decisional conflict(3 months after surgery (T2); 12 months after surgery (T3))
- decision regret(3 months after surgery (T2); 12 months after surgery (T3))
- actual choice(3 months after surgery (T2); 12 months after surgery (T3))
- satisfaction with outcome(3 months after surgery (T2); 12 months after surgery (T3))
- knowledge about breast reconstruction(1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3))
- preparedness for decision making(1 week after consultation with a plastic surgeon (T1))
- body image(3 months after surgery (T2); 12 months after surgery (T3))
- sexual functioning(3 months after surgery (T2); 12 months after surgery (T3))
- satisfaction with information(1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3))
- satisfaction with plastic surgeon(1 week after consultation with plastic surgeon (T1))
- patient's perception of shared decision making(1 week after consultation with a plastic surgeon (T1))
- breast symptoms(3 months after surgery (T2); 12 months after surgery (T3))
- anxiety(1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3))