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

NCT06415162 | Recruiting

• 1 other identifier: SaglikBilimleriUBTURKMEN0001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Hormone therapy; Breast cancer; Cooling pillowcase; Hot flashes; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  nine weeks

Secondary Outcomes (2)

• The Pittsburgh Sleep Quality Index

  nine weeks

• Functional Assessment Of Cancer Therapy-Breast (FACT-B)

  nine weeks

Study Arms (2)

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.

Other: Cooling Pillowcases

Control Group

NO INTERVENTION

No intervention will be given to the patients in the control group.

Interventions

Cooling Pillowcases OTHER

No intervention will be given to the patients in the control group.

Also known as: Control group

Cooling Pillowcases

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Science

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Basak Turkmen, Msc.

  University of Health science

  PRINCIPAL INVESTIGATOR

• Semiha Akin Eroglu, Prof.

  University of Health science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Turkmen, Msc.

CONTACT

+905377217410; basak.turkmen4234@gmail.com

Semiha Akin Eroglu, Prof.

CONTACT

+902167779317; semihaakin@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Student Internal Medicine Nursing

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: December 19, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)