Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415162
• Other study ID #: SaglikBilimleriUBTURKMEN0001
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Saglik Bilimleri Universitesi
• Contact: Basak Turkmen, Msc.
• Phone: +905377217410
• Email: basak.turkmen4234[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Cooling Pillowcases
No intervention will be given to the patients in the control group.

Locations

Country	Name	City	State
Turkey	University of Health Science	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal Hot Flush Scale	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.	nine weeks
Secondary	The Pittsburgh Sleep Quality Index	The scale consists of 7 sub-dimensions. Each of the questions including the sub-dimension is scored between 0-3. The total score of the seven sub-dimensions varies between 0-21 and gives the total score of The Pittsburgh Sleep Quality Index. A total score above 5 indicates poor sleep quality.	nine weeks
Secondary	Functional Assessment Of Cancer Therapy-Breast (FACT-B)	The responses in the scale are organised in a 5-point Likert scale where '0' means not at all, '1' means very little, '2' means a little, '3' means quite a lot and '4' means very much. Some of the statements in the scale are reversed, and while calculating the total score of the scale, the reversed statements are subtracted from four and the other statements are directly added to the scoring. The total score that can be obtained from the scale varies between 0-148. A higher total score indicates a better quality of life.	nine weeks