Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 4
- 主要终点
- Fear of Progression
研究概览
简要总结
The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.
详细描述
A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.
The aims are to test:
- the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and
- the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.
Primary hypothesis:
- Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.
- Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.
- Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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 CALM or control arms.
The participants are masked in terms of not knowing that the interventions (i.e. Conquer fear and CALM) are 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 advanced or metastatic (i.e. stage III or IV) cancer
- are the age of 18 years or above
排除标准
- Patients with major communication difficulties
- are being unwilling or unable to commit 6 psychotherapy sessions
研究组 & 干预措施
ConquerFear intervention
Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.
干预措施: ConquerFear intervention (Behavioral)
CALM intervention
Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.
干预措施: CALM intervention (Behavioral)
Basic Cancer Care
Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.
干预措施: Basic Cancer Care (Behavioral)
结局指标
主要结局
Fear of Progression
时间窗: Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention
The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.
次要结局
- Metacognitions(Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention)
- Depression(Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention)
- Death anxiety(Baseline, the immediate post-intervention, 3-months post-intervention and 6-months post-intervention)
研究者
Wendy Wing Tak Lam
Associate Professor
The University of Hong Kong
研究点 (4)
标识符
- NCT 编号
- NCT05679518
- 其他研究编号
- UW22-036
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (3个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
All IPD that underlie results in a publication will be available from the PI upon reasonable request.