The Effect of Metacognition-based, Manualized Intervention on Fear of Cancer Recurrence: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 7
- 主要终点
- Fear of cancer recurrence
研究概览
简要总结
The primary aim of this study is to assess the effect of ConquerFear, a metacognition-based manualized intervention on fear of cancer recurrence, using the randomized controlled trial approach, among Chinese patients newly diagnosed with curable cancer. This study aims to (1) test the direct effect of ConquerFear intervention on fear of cancer recurrence and on maladaptive metacognition, and (2) to test the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.
详细描述
A randomized controlled trial will be conducted to test the effect of a metacognition-based manualized intervention on fear of cancer recurrence among Chinese breast, gynecologic and colorectal cancer patients with high levels of fear of cancer recurrence.
The aims are to test:
- the direct effect of ConquerFear intervention on fear of cancer recurrence,
- the direct effect of ConquerFear intervention on maladaptive metacognition
- the indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.
Primary hypothesis:
- Participants in the ConquerFear intervention will show a greater reduction in fear of cancer recurrence compared to participants in the control group
- Participants in the ConquerFear intervention will show a greater reduction in maladaptive metacognition than the control participants
- There will be an indirect effect of ConquerFear intervention on fear of cancer recurrence through its effect on maladaptive metacognition.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or control arms.
The participants are masked in terms of not knowing that one intervention (i.e. Conquer fear) is hypothesized to yield larger effects than the other (i.e. control).
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
- •Cantonese- or Mandarin-speaking Chinese patients recently diagnosed with non-metastatic breast cancer, gynecologic cancer, or colorectal cancer
- •had surgery as a primary treatment
- •have had completed hospital-based adjuvant treatments including radiotherapy and chemotherapy within the past 18 months
- •with the cut-off scored ≥ 13 on Severity, the subscale of Fear of cancer inventory
- •are able to read and write Chinese
- •are over the age of 18 years
排除标准
- •non-Chinese ethnicity
- •Patients diagnosed with metastatic cancer
- •with a current diagnosis of depression or psychosis
- •currently receiving psychological treatment
- •with language difficulties or intellectual disability.
结局指标
主要结局
Fear of cancer recurrence
时间窗: Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention
The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.
次要结局
- EORTC QLQ-C30(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Cognitive Attentional Syndrome(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Psychological distress(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Treatment satisfaction(Immediate post-intervention)
- Metacognitions(Baseline, immediate post-intervention, 3months post-intervention, and 6months)
- Self-efficacy(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Coping behavior(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Experimental avoidance(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Cancer-related distress(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
- Treatment expectancy(Baseline and immediate post-intervention)
- Therapeutic alliance(Immediate post-intervention)
- Intolerance of uncertainty(Baseline, immediate post-intervention, 3months post-intervention, and 6months post-intervention)
研究者
Wendy Wing Tak Lam
Associate Professor
The University of Hong Kong