Using cooling pillowcases to help manage hot flashes and improve sleep in breast cancer patients
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
NA · Saglik Bilimleri Universitesi · NCT06415162
This study is testing if cooling pillowcases and education can help women with breast cancer manage hot flashes and sleep better during hormone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Saglik Bilimleri Universitesi (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06415162 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of educational interventions and the use of cooling pillowcases on hot flush symptoms, sleep quality, and overall life quality in women with breast cancer undergoing hormone therapy. Participants will be divided into an intervention group, receiving education and cooling pillowcases, and a control group, receiving standard care without additional interventions. Assessments will be conducted at the beginning and end of the study, with follow-ups to monitor progress and effectiveness of the interventions. The goal is to determine if these methods can alleviate discomfort and enhance quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with hormone receptor-positive breast cancer who are currently receiving hormone therapy.
Not a fit: Patients with a history of sleep disorders prior to hormone therapy or those receiving treatment for anxiety or depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to alleviate hot flashes and improve sleep quality for breast cancer patients undergoing hormone therapy.
How similar studies have performed: While the specific use of cooling pillowcases is novel, similar studies have shown that educational interventions can effectively manage side effects in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul
- University of Health Science — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Basak Turkmen, Msc. — University of Health science
- Study coordinator: Basak Turkmen, Msc.
- Email: basak.turkmen4234@gmail.com
- Phone: +905377217410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Hormone therapy, Breast cancer, Cooling pillowcase, Hot flashes, Quality of life