Breast CancerNCT06415162
Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality
A study testing Cooling Pillowcases in people with Breast Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cooling Pillowcases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Science
Istanbul
Basak Turkmen
Semiha Akin Eroglu
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Cooling Pillowcases
- Keywords
- Hormone therapy, Breast cancer, Cooling pillowcase, Hot flashes, Quality of life
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling PillowcasesOther
Also called Control group
No intervention will be given to the patients in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Cooling Pillowcases | Experimental | The intervention group will be given 'Patient Information Form, Menopause Specific Hot Flash Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' to be filled in the 1st week, training on treatment side effects, training booklet and 'Hot Flash Diary' to record the hot flashes they experience. A cooling pillowcase will be given and its use 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 given and the training will be repeated. A total of 3 follow-ups will be carried out by using the 'Patient Follow-up Form' by telephone in the 3rd and 7th weeks and face-to-face interview in the 5th week. In the 9th week, 'Menopause Specific Hot Flush Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' and 'Practices for Coping with Side Effects of Hormone Therapy Form' will be completed to evaluate the effectiveness of the retraining given in the 5th week. Receives: Other: Cooling Pillowcases |
| Control Group | No intervention | No intervention will be given to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: nine weeks
Secondary outcomes (2)
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.
Measured: nine weeks
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.
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start19 Dec 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak Türkmen, Saglik Bilimleri Universitesi
- Investigators
- Basak Turkmen, Msc., Principal investigator, University of Health scienceSemiha Akin Eroglu, Prof., Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415162
- Sponsor's protocol ID
- SaglikBilimleriUBTURKMEN0001
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06415162
- Acronym / sponsor ID
- SaglikBilimleriUBTURKMEN0001
- Conditions
- Breast Cancer
- Keywords
- Hormone therapy, Breast cancer, Cooling pillowcase, Hot flashes, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cooling Pillowcases | Experimental | Other: Cooling PillowcasesThe intervention group will be given 'Patient Information Form, Menopause Specific Hot Flash Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' to be filled in the 1st week, training on treatment side effects, training booklet and 'Hot Flash Diary' to record the hot flashes they experience. A cooling pillowcase will be given and its use 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 given and the training will be repeated. A total of 3 follow-ups will be carried out by using the 'Patient Follow-up Form' by telephone in the 3rd and 7th weeks and face-to-face interview in the 5th week. In the 9th week, 'Menopause Specific Hot Flush Scale, Pittsburgh Sleep Quality Index and FACT-B Quality of Life Scale' and 'Practices for Coping with Side Effects of Hormone Therapy Form' will be completed to evaluate the effectiveness of the retraining given in the 5th week. |
| Control Group | No intervention | –No intervention will be given to the patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling PillowcasesAlso: Control groupNo intervention will be given to the patients in the control group. | Other | Cooling Pillowcases |
Primary outcome
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.
2 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: nine weeks
Functional Assessment Of Cancer Therapy-Breast (FACT-B)
Time frame: nine weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Turkmen, Msc. principal investigator
University of Health science
Semiha Akin Eroglu, Prof. principal investigator
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Pillowcases in people with Breast Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basak Turkmen, Msc. (+905377217410, basak.turkmen4234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal Hot Flush Scale (time frame: nine weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.