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临床试验/NCT06415162
NCT06415162招募中不适用

Evaluation of the Effects of Education on Side Effects Management and the Use of Cooling Pillowcases on Hot Flash Complaints, Sleep and Quality of Life in Women With Breast Cancer Receiving Hormone Therapy

Saglik Bilimleri Universitesi2 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2023年12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
64
试验地点
2
主要终点
Menopausal Hot Flush Scale

研究概览

简要总结

This study was planned to evaluate the effect of education on the management of side effects and the use of cooling pillowcase on hot flush complaints, sleep and quality of life in women with breast cancer receiving hormone therapy.

详细描述

It is planned to apply pre-test evaluations in the 1st week and post-test evaluations in the 9th week to the intervention (training) group consisting of women with breast cancer who agree to participate in the study. A total of 3 follow-ups will be performed on the patients in the intervention (education) group in weeks 3 and 7 by telephone interview method and in week 5 by face-to-face interview method using the Patient Follow-up Form. In addition, in order to evaluate the effectiveness of the education given to the patients in the intervention (education) group, the Practices for Coping with the Side Effects of Hormone Therapy Form will be completed in the 5th and 9th weeks.

The control group consisting of women with breast cancer who agreed to participate in the study will be administered pre-test evaluations at week 1 and post-test evaluations at week 9. The patients in the control group will not be subjected to any intervention by the researcher, their routine treatment and care will continue, and they will be followed up only once in the 5th week by phone call.

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
None

入排标准

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

入选标准

  • 18 years of age or older,
  • Estrogen and progesterone receptor positive, stage 1, 2, 3 or 4 primary breast cancer,
  • Receiving hormone therapy (goserelin acetate subcutaneously every 4 weeks),
  • Pre/Perimenopausal period,
  • No sensory and emotional barriers to communication,
  • Understands Turkish, can read and write,
  • Patients who voluntarily agreed to participate in the study.

排除标准

  • Receiving treatment for anxiety and/or depression,
  • Receiving gabapentin treatment for neuropathic pain,
  • Active viral or bacterial infection,
  • Patients with a history of sleep disorders diagnosed before hormone therapy.

结局指标

主要结局

Menopausal Hot Flush Scale

时间窗: nine weeks

All items in the scale are evaluated between '0' and '10' points. The highest score that can be obtained from the scale is '100' and the lowest score is '0'. The higher the score obtained from the scale, the higher the woman's level of being affected by hot flushes.

次要结局

  • Functional Assessment Of Cancer Therapy-Breast (FACT-B)(nine weeks)
  • The Pittsburgh Sleep Quality Index(nine weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Başak Türkmen

Phd Student Internal Medicine Nursing

Saglik Bilimleri Universitesi

研究点 (2)

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