A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Fear of cancer recurrence
研究概览
简要总结
The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.
详细描述
A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.
The aims are to:
- Evaluate the efficacy of CF-G on FCR,
- Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
- Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.*
- Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.
Primary hypothesis:
CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The investigator and assessor is masked in terms of not knowing to which condition the participants will be randomized until after completion of the baseline assessment. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
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
- •Eligible patients have a confirmed past diagnosis of stage 1-3 breast cancer,
- •have been treated with curative intent,
- •have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry,
- •are disease free,
- •scores in the clinical range (≥22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF),
- •are able to read and write Danish,
- •are over the age of 18 years, and
- •are able to give informed consent.
排除标准
- •self-reported current major depression,
- •currently receiving psychological treatment from a therapist not involved in the study,
- •self-reported active psychotic illness or other severe psychiatric conditions.
结局指标
主要结局
Fear of cancer recurrence
时间窗: Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up
Changes in fear of cancer recurrence will be measured with the 42-item Fear of Cancer Recurrence Inventory at baseline, 1 week post intervention, 3- and 6-months follow-up, and session-by-session with the 9-item Fear of Cancer Recurrence Inventory-Short Form
次要结局
- Negative effects of intervention(One week post intervention, 3- and 6-months follow-up)
- Sleep(Baseline, one week post intervention, 3- and 6-months follow-up)
- General distress 1(Baseline, one week post intervention, 3- and 6-months follow-up)
- General distress(Baseline, one week post intervention, 3- and 6-months follow-up)
- Survivors' unmet needs(Baseline, one week post intervention, 3- and 6-months follow-up)
- Emotion regulation(Baseline, one week post intervention, 3- and 6-months follow-up)
- Fear of cancer recurrence(Baseline, one week post intervention, 3- and 6-months follow-up)
- Metacognitions(Baseline, one week post intervention, 3- and 6-months follow-up)
- Mindfulness(Baseline, one week post intervention, 3- and 6-months follow-up)
- Intervention satisfaction(One week post intervention, 3- and 6-months follow-up)
- Health-related quality-of-life(Baseline, one week post intervention, 3- and 6-months follow-up)
研究者
Nina M. Tauber
MSc
Aarhus University Hospital