跳至主要内容
临床试验/NCT05606549
NCT05606549招募中不适用

Effect of Marital Self Disclosure Intervention on Fear of Cancer Recurrence and Dyadic Coping Ability Among Gastric Cancer Survivors and Their Spouse

University of Malaya1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners

研究概览

简要总结

The goal of this clinical trial is to explores the effect of marital self disclosure intervention on fear of cancer recurrence and dyadic coping ability in gastric cancer survivors and their spouses. The main questions are: What is the level of fear of cancer recurrence among gastric cancer survivors and their spouse? What is the level of dyadic coping ability among gastric cancer survivors and their spouse?What is the effect of marital self-disclosure intervention on fear of cancer recurrence and dyadic coping ability in the gastric cancer survivors and their spouses? Participants will accept the intervention of marital self disclosure for 4 times (4 cycles of chemotherapy) with different topics. Researchers will compare with control group to see if the level of fear of cancer recurrence and dyadic coping ability will be improved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The disease meets the diagnostic criteria of "Guidelines for Diagnosis and Treatment of Gastric Cancer"(Department of Medical Affairs, 2019), the preoperative gastroscopy and pathological diagnosis are advanced gastric cancer, and the postoperative pathological classification is type II, III or IV
  • Age ≥ 18 years
  • Able to write and oral communicate effectively by themself
  • The main caregiver is their spouse
  • Clear consciousness, no understanding barriers
  • Agree to participate in this study

排除标准

  • History of receiving a structured psychological intervention from a psychiatrist or a psychologist
  • Cognitive disorders or psychiatric disorders (according to the DSM-V)
  • Severe visual, hearing and speech impairment
  • With previous or concurrent malignant tumors
  • With severe complications, such as gastrointestinal obstruction, perforation, etc.

结局指标

主要结局

Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Partners

时间窗: 4 months

FoP-Q-SF for Partners is developed by Zimmermann et al. (2011) based on the structure of the FoP-Q-SF scale to assess the degree of disease progression of the patient's spouse's fear of disease. FoP-Q-SF for Partners includes 12 items, adopting 5-point Likert scale, 1 point representing "never" and 5 points representing "always", with a total score ranging from 12 to 60, with higher scores indicating higher fear of their spouse's disease progression.

Fear of Progression Questionnaire-Short form (FoP-Q-SF) for Patients

时间窗: 4 months

The FoP-Q-SF is a one-dimensional scale constructed by on the basis of the Fear of Progression Questionnaire (FoP-Q). The FoP-Q-SF for Patients scale includes 12 items, using 5-point Likert Scale, 1 point means "never", 5 points means "always", with a total score ranging from 12 to 60, with higher scores indicating higher fear of disease progression.

次要结局

  • Dyadic Coping Inventory(DCI)(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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