跳至主要内容
临床试验/CTRI/2024/06/069463
CTRI/2024/06/069463已完成不适用

Effectiveness of Psychosocial Intervention on Distress, Body Image Satisfaction and Quality of Life among Colorectal Cancer Patients: An Intervention Study

Malabar Cancer Centre1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年7月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
improvement of distress, body image satisfaction, quality of life

研究概览

简要总结

The study aims to evaluate the effectiveness of psychosocial intervention on distress, body image satisfaction and quality of life among CRC patients who underwent curative intent surgery. To measure these variables, Distress Thermometer (NCCN DT), Body image Scale (BIS), EORTC Quality of Life (EORTC QLQ- C30) and EORTC QLQ – CR29 will be used. The study uses Pretest-Posttest Randomized Control Group Design. The sample size for descriptive study is 94 CRC patients and 12 CRC patients for intervention study (6 in each group). Purposive Sampling will be used for descriptive design. Simple Random sampling will be used for phase 2 intervention study.

The intervention phase of the study involves two groups - control group who will be provided with single session conventional intervention and intervention group who will be given 3 session psychosocial intervention module. The participants intervention study will be recruited based on a score of 4 or above on NCCN DT.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Individuals diagnosed with Colorectal Cancer (Stages I/II/III) .
  • Individuals who underwent curative intent colorectal cancer surgery with or without neoadjuvant treatment.
  • Individuals who can read, write and understand English or Malayalam.
  • Individuals with a responsible bystander.

排除标准

  • Patients with any known psychiatric or psychological conditions.
  • Patients with a known history of sensory impairment or physical disabilities or Intellectual Disability.
  • Patients with a known history of epilepsy or other brain related impairments, underwent major cardiovascular surgeries, and neurological conditions.
  • Patients undergoing Palliative intent treatment.

结局指标

主要结局

improvement of distress, body image satisfaction, quality of life

时间窗: Post surgery after 3 days | 3 days to 2 weeks after first follow up | 3 days to 2 weeks after second follow up

次要结局

  • relationship between distress, body image satisfaction and quality of life among colorectal cancer patients(post surgery - after 3 days)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jisha Abraham

Malabar Cancer Centre

研究点 (1)

Loading locations...

相似试验