Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Stress
研究概览
简要总结
- Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
- Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group.
- The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.
详细描述
After completing the baseline HRQoL assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial.
Those who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.
The intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).
Outcome measures include measures of perceived stress and HRQoL.
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 (Investigator, Outcomes Assessor)
盲法说明
Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first occurrence breast cancer diagnosed from Jan 1, 2020
- •non-metastatic cancer stage 0-III
- •Invasive tumors must be:
- •HER2 positive (regardless of ER, PR) or
- •ER negative
- •(may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)
排除标准
- 未提供
结局指标
主要结局
Stress
时间窗: change from CABC baseline (week 0) to f-up week 21
Cohens perceived stress scale. Unit is summary score.
次要结局
- Anxiety and depression(change from CABC baseline (week 0) to f-up month 27)
- Neuropathy (FACT GOG-NTX and -ES)(From NBCR baseline to f-up month 27)
- Coping(change from CABC baseline (week 0) to f-up month 27)
- EORTC QLQ-BR23(change from NBCR baseline to f-up month 27)
- Subjective health (HRQoL)(change from CABC baseline (week 0) to f-up month 27)
- Fatigue(change from CABC baseline (week 0) to f-up month 27)
- Mindfulness(change from CABC baseline (week 0) to f-up month 27)
- Sleep(change from CABC baseline (week 0) to f-up month 27)
- EORTC QLQ-C30(change from NBCR baseline to f-up month 27)
- Work(status at f-up month 15)
- Stress(change from CABC baseline (week 0) to f-up month 27)