The Efficacy of a Brief Oncologist-delivered Intervention for Fear of Cancer Recurrence: A Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Fear of cancer recurrence
研究概览
简要总结
The investigators will test a novel Clinician-led Intervention to address Fear of cancer Recurrence in cancer survivors (CIFeR), by 1) adapting the original Australian intervention manual to the Danish oncology context (CIFeR-DK), and 2) developing a brief e-learning program to train oncologists. The investigators will then 3) compare CIFeR-DK with an active control condition in a cluster-randomized controlled trial with 24 oncologists (the cluster unit) treating a minimum of 300 patients with breast, ovarian, lung and prostate cancer at Danish Oncology Departments at four hospitals in Aarhus, Vejle, Aalborg, and Copenhagen, and 4) explore fidelity, acceptability, feasibility, and perceived barriers and facilitators to use the intervention in routine follow-up care.
详细描述
STUDY DESIGN:
The study is designed as a parallel cluster-randomized controlled trial with oncologists (cluster unit) treating breast, ovarian, and prostate cancer at the oncology departments at Aarhus University Hospital (AUH), Vejle Hospital (VH), Aalborg University Hospital (AAUH), and Copenhagen University Hospital (CUH), and randomized 1:1 to intervention versus active control.
Participants:
All oncologists treating breast, ovarian, and prostate cancer at the participating departments are eligible for the study and will be recruited by our collaborators at the participating departments. Eligible patients score >= 13 on the FCRI-SF and have completed their primary treatment i.e., surgery, adjuvant chemotherapy, and/or radiotherapy, for breast, ovarian, lung and prostate cancer at the participating departments between three weeks and three months previously.
Procedure:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ≥ 18 years old
- •Have completed their primary treatment, i.e., surgery, adjuvant chemotherapy, and/or radiotherapy, for breast, ovarian, prostate, or lung cancer at the participating departments between three weeks and three months previously.
- •Score >= 13 on the FCRI-SF
排除标准
- 未提供
结局指标
主要结局
Fear of cancer recurrence
时间窗: T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention)
Assessed with the 9-item Fear of Cancer Recurrence Inventory Short Form (FCRI-SF), range 0-36. Higher scores indicate worse outcome
次要结局
- Patient reported intervention usefulness(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
- Metacognition(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
- Anxiety and depression(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
- Unmet needs(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
- General Quality of Life (QoL)(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
- Rumination(T1 (2 weeks prior to intervention), T2 (one week post intervention), T3 (three months post intervention))
研究者
Prof. Robert (Bobby) Zachariae
Professor
Aarhus University Hospital