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临床试验/NCT06457178
NCT06457178招募中不适用

Investigation of the Effect of Acceptance and Commitment Therapy-Based Intervention on Psychological Distress and Reintegration Into Normal Life in Oncology Patients

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
2
主要终点
The Distress Thermometer (DT)

研究概览

简要总结

The goal of this clinical trial is to investigate the effectiveness of Acceptance and Commitment Therapy Based Intervention for Oncology Patients. The main questions it aims to answer are:

  • Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of psychological distress?
  • Does the Acceptance and Commitment to Therapy-Based Intervention for Oncology Patients affect the level of reintegration into normal life?

Researchers will compare Acceptance and Commitment Therapy-Based Intervention for Oncology Patients (ACT) to Psychoeducation for Oncology Patients and routine care (with no specific intervention) to see if Acceptance and Commitment Therapy-Based Intervention for Oncology Patients is effective in psychological distress and reintegration into normal living.

详细描述

Participants:

  • They will be randomly divided into three groups (Group 1: ACT, Group 2: Psychoeducation, Group 3: Routine care).
  • All participants will be asked to complete data collection forms.
  • Group 1 will participate in a 5-session Acceptance and Commitment Therapy-Based Intervention for Oncology Patients intervention program.
  • Group 2 will participate in a 5-session Psychoeducation for Oncology Patients program.
  • During this period, participants in group 3 will continue their routine treatment.
  • After completion of the interventions, participants will be asked to complete the data collection forms again.
  • The researchers will then analyze the results and write the report.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older,
  • Being able to read and write,
  • Receiving oncologic treatment,
  • Being diagnosed with breast cancer,
  • To know about Medical Diagnosis,
  • Being in stage 1, 2 or 3 of the disease,
  • Receiving outpatient chemotherapy treatment only,
  • Internet access and computer skills to participate in online group interviews,
  • Low to moderate scores on the brief psychological resilience scale,

排除标准

  • Having serious psychiatric or cognitive impairments that limit adherence to group sessions,
  • Having a physical disability that may make it difficult to participate in group sessions,
  • Failure to attend sessions regularly and absenteeism,
  • Currently being in a psychoeducation/psychotherapy group

结局指标

主要结局

The Distress Thermometer (DT)

时间窗: one month after the end of the interventions

The scale was developed to measure psychological distress in cancer patients. The problems in the list are grouped into five areas. These are daily life problems, family problems, emotional problems, faith-related problems, and physical problems. The patient marks which one or which areas of the list he/she has experienced problems in the last week. The cut-off point of the scale in our country was found to be 4. The National Comprehensive Cancer Network (NCCN) argues that patients who score 5 or above on the distress thermometer are in significant distress and should be supported by professionals.

次要结局

  • Reintegration to Normal Living Index (RNLI)(one month after the end of the interventions)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilara Sert Kasım

Doctorate Student

Istanbul University - Cerrahpasa

研究点 (2)

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