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

May 10, 2024 updated by: Başak Türkmen, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • University of Health Science
        • Contact:
          • Basak Turkmen
        • Contact:
          • Semiha Akin Eroglu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cooling Pillowcases
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.
Other: Cooling Pillowcases
No intervention will be given to the patients in the control group.
Other Names:
  • Control group
No Intervention: Control Group
No intervention will be given to the patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
nine weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index
Time Frame: nine weeks
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
Functional Assessment Of Cancer Therapy-Breast (FACT-B)
Time Frame: nine weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Basak Turkmen, Msc., University of Health Science
  • Principal Investigator: Semiha Akin Eroglu, Prof., University of Health Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SaglikBilimleriUBTURKMEN0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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