Clinical trial NCT06415162: Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Hormone therapy
Breast cancer
Cooling pillowcase
Hot flashes
Quality of life
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will fill in the 'Patient Information Form, Menopause Specific Hot Flash Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' in the 1st week and will be given training on treatment side effects, training booklet and 'Hot Flash Diary' to record their hot flashes. The use of cooling pillowcase will be explained. In the 5th week, 'Practices for Coping with the Side Effects of Hormone Therapy Form' will be filled out to evaluate the training and the training will be repeated. In the 3rd and 7th weeks, 'Patient Follow-up Form' will be filled by telephone, and in the 5th week face to face. In the 9th week, 'Menopause Specific Hot Flush Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' and 'Practices Form for Coping with Side Effects of Hormone Therapy' will be completed to evaluate the training given in the 5th week. The routine care and treatment of the control group will be continued.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Menopausal Hot Flush Scale
timeFrame: nine weeks
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: nine weeks
measure: Functional Assessment Of Cancer Therapy-Breast (FACT-B)
timeFrame: nine weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Science
Study officials:
affiliation: University of Health science
name: Basak Turkmen, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health science
name: Semiha Akin Eroglu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: