NCT07054957

Brief Summary

Hot flushes are a common symptom in women with breast cancer receiving hormone therapy. It can lead to conditions that reduce quality of life such as sleep quality deterioration, sexual problems and discomfort in daily life. Effective management of the symptom improves the quality of life of patients. The aim of the study was to examine the effect of handheld fan use in the management of hot flashes in women with breast cancer receiving hormone therapy. Hypotheses of the research: H1: Handheld fan use has no effect in managing hot flashes in women with breast cancer receiving hormone therapy. H2: The use of handheld fan has an effect on the management of hot flashes in women with breast cancer receiving hormone therapy. This randomised controlled study was a pretest-posttest experimental design. The study sample consisted of 64 breast cancer patients (n = 32 for each of the intervention and control groups) receiving hormone therapy treatment in the medical oncology department of a university hospital. The intervention group used a hand-held fan when experiencing hot flush symptoms, while the control group did not receive any intervention. The pre-test and post-test Visual Analogue Scale (VAS) and hot flush belief scale scores and the results of the individual identifying information form were compared for both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

June 3, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

breast cancerhormonetherapyhandheld fanhot flashessymptom management

Outcome Measures

Primary Outcomes (3)

  • Individual Information Form

    This form contains questions about sociodemographic characteristics, diseases and symptoms.

    12 weeks

  • Visual Analog Scale (VAS)

    Visual Analog Scale (VAS); VAS is used to quantify some values that cannot be measured numerically. It consists of a 10 cm long line at one end, which is expressed as very good for the individual/patient and very bad at the other end. VAS is also a valid and reliable measurement tool for measuring other subjective emotions such as mood. In this study, VAS is preferred for the hot flashes experienced by women with breast cancer receiving hormone therapy

    12 weeks

  • Hot Flashes Belief Scale

    The scale consists of 27 items and three sub-dimensions. The beliefs about oneself in a social context sub-dimension: It was formed with 13 items (1, 6-11, 13, 14, 17, 20, 21, 23) that describe how women feel when they experience hot flashes in social environments. The beliefs about coping with hot flashes sub-dimension: It was formed with 10 items (2, 5, 12, 15, 16, 18, 19, 24, 26, 27) that describe beliefs about coping with hot flashes. Beliefs about coping with night sweats sub-dimension: It consists of 4 items (3, 4, 22, 25) describing women's beliefs about coping with night sweats. Each item of the scale is rated on a 6-point Likert type scale ranging from "strongly disagree" (0 points) to "strongly agree" (5 points). It is stated that items 2, 4, 5, 11, 15, 18, 25 of the scale are reverse coded. The total score of the scale varies between 0-135, and a high score on the scale indicates a high level of negative belief.

    12 weeks

Study Arms (2)

Control group

NO INTERVENTION

pre-test, mid-test and final test will be administered.

İntervention group

EXPERIMENTAL

Group using hand fans

Other: Handheld fanOther: Control Group

Interventions

Group using hand fans

İntervention group

pre-test, mid-test and post-test will be administered.

İntervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMANAGEMENT OF HOT FLASHES IN WOMEN WITH BREAST CANCER RECEIVING HORMONETHERAPY
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of clinical breast cancer
  • Experiencing hot flashes

You may not qualify if:

  • \- Menopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, Seyrek/Menemen, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study was conducted in a single-blind, single-center, randomized controlled design in breast cancer patients receiving hormone therapy in an outpatient chemotherapy unit. This study was conducted in the outpatient chemotherapy unit of a training and research university hospital in Turkey between November 2023 and October 2024.: This randomised controlled study was a pretest-posttest experimental design. The study sample consisted of 64 breast cancer patients (n = 32 for each of the intervention and control groups) receiving hormone therapy treatment in the medical oncology department of a university hospital. The intervention group used a hand-held fan when experiencing hot flush symptoms, while the control group did not receive any intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

July 8, 2025

Study Start

November 15, 2023

Primary Completion

January 15, 2024

Study Completion

October 15, 2024

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations