Skip to main content
Clinical Trials/NCT06415162
NCT06415162
Recruiting
Not Applicable

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 Universitesi1 site in 1 country64 target enrollmentDecember 19, 2023
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Saglik Bilimleri Universitesi
Enrollment
64
Locations
1
Primary Endpoint
Menopausal Hot Flush Scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 19, 2023
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Başak Türkmen

Phd Student Internal Medicine Nursing

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Menopausal Hot Flush Scale

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials