Communication in Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
The investigators will create 4 information-video's about chemotherapy side-effects in curative breast cancer care. The communication is manipulated in the four videos. Participants will watch the video before the first chemotherapy and complete questionnaires before and after viewing the video and after chemotherapy 1,2 and 4. (The investigators cannot yet reveal the manipulation as it would influence the participants)
详细描述
NA, the investigators cannot yet reveal the manipulation as it would influence the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Adult (>18 years old) female breast cancer patients
- •Chemo-naïve patients
- •Scheduled in for curative neo-adjuvant chemotherapy: Four courses of AC chemotherapy (all combinations of AC + other chemotherapy courses are eligible)
- •Cognitively able to fill out an online questionnaire
- •Having internet access
- •Sufficient command of the Dutch language
- •pre-chemo no previous treatment or pre-chemo breast-conserving surgery and radiotherapy (WLE patients)
排除标准
- 未提供
结局指标
主要结局
Anxiety
时间窗: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed
measuring the change in anxiety measured using a shortened version of the State-Trait Anxiety Inventory (STAI-S)
次要结局
- information needs(Day 0 (day before chemo 1))
- psychological outcomes(Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed)
- medical outcomes(day 54 (12 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed)
- socio-demographics(Day 0 (day before chemo 1))
- anxiety(trait: Day 0 (day before chemo 1), current: Day 0 (day before chemo 1), day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and dday 52-54 (10 days after chemo 4).)
- side effects (expected and experienced)(expected: Day 0 (day before chemo 1); experienced: day 7-10 (week after chemo 1), day 21-23 (week after chemo 2), and day 52-54 (10 days after chemo 4). (This might be subject to change in cases where the days of the chemo therapy are changed)
研究者
lmvanvliet
Assistant Professor
Leiden University