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Trial Title:
Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality
NCT ID:
NCT06415162
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Hormone therapy
Breast cancer
Cooling pillowcase
Hot flashes
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cooling Pillowcases
Description:
No intervention will be given to the patients in the control group.
Arm group label:
Cooling Pillowcases
Other name:
Control group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Health Science
Address:
City:
Istanbul
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Basak Turkmen
Contact backup:
Last name:
Semiha Akin Eroglu
Start date:
December 19, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Saglik Bilimleri Universitesi
Agency class:
Other
Source:
Saglik Bilimleri Universitesi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415162
