NCT06574256

Brief Summary

The aim of the study was to examine the effect of online nursing education given to women diagnosed with gynecological cancer and receiving chemotherapy. It was conducted as a randomized controlled experimental study. The study examined the effect of online nursing education given to patients in the intervention group diagnosed with gynecological cancer and receiving chemotherapy on symptoms, quality of life and patient satisfaction. The control group received routine nursing care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 21, 2024

Last Update Submit

August 24, 2024

Conditions

Keywords

gynecological cancersymptom managementtelenursingquality of lifechemotherapy

Outcome Measures

Primary Outcomes (2)

  • EORT QLQ-C30

    EORT QLQ-C30: It consists of three main dimensions and 30 questions, namely general well-being, functional difficulties and symptom control.

    three monhts

  • Nightingale symptom assessment scale

    Nightingale symptom assessment scale: This scale, consisting of 38 items, has three sub-dimensions, namely physical, social and psychological well-being.

    three monhts

Secondary Outcomes (3)

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,

    three monhts

  • Nightingale Symptom Assessment Scale

    three months

  • patient satisfaction

    one months

Study Arms (2)

intervention group

EXPERIMENTAL

Patients in the intervention group will receive online nursing education and their quality of life and symptom complaints will be monitored by the nurse who provides education during three cycles of chemotherapy. At the end of the third cycle, patients' satisfaction with this education will be determined.

Other: Chemotherapy symptom Management Online Education

control group

NO INTERVENTION

Patients in the control group will receive routine nursing care. Patients in the control group will be monitored for quality of life and symptom complaints during three cycles of chemotherapy.

Interventions

Randomization was achieved and data collection began. Patients were given the "Chemotherapy Symptom Management Education Booklet" and were informed that they would be contacted by phone. In the second and third stages of data collection, they were called by phone on the 7th day after receiving chemotherapy treatment. The symptoms experienced by the patient were evaluated with the N-SDS and the quality of life was evaluated with the EORTC QLQ-C30. Online nursing education videos were sent to the women in the intervention group regarding the symptoms they experienced. The practices they performed from the suggestions in the education videos and education booklets sent were recorded on the nurse follow-up form. In the fourth stage, the practices specified in the third stage were repeated on the 7th day after the third chemotherapy course, and at this stage, the satisfaction of the women in the intervention group with the online education was evaluated.

Also known as: Chemotherapy symptom Management, nursing online education
intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients diagnosed with gynecological cancer and receiving chemotherapy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with gynecological cancer and who have started chemotherapy treatment for the first time in the hospital,
  • having gynecological cancer
  • receiving chemotherapy
  • Speak Turkish, have no communication problems,
  • Accept voluntarily to participate in the study,
  • Patients who are 18 years of age or older

You may not qualify if:

  • Illiterate Patients who do not have a smart phone or computer Patients who receive radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CelalBayarU

Manisa, 45010, Turkey (Türkiye)

Location

Study Officials

  • ayşegül beyazpınar kavaklıoğlu, student

    Celal Bayar University

    PRINCIPAL INVESTIGATOR
  • emre yanıkkerem, prof.dr.

    Celal Bayar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The universe of the study consisted of 114 women. The sample of the study consisted of 90 women. Inclusion Criteria for the Study Patients diagnosed with gynecological cancer and starting chemotherapy treatment for the first time in the hospital Speaking Turkish, having no communication problems Agreeing to participate in the study voluntarily Patients aged 18 and over Exclusion Criteria for the Study Illiterate Do not have a smart phone or computer Receiving radiotherapy together with chemotherapy Patients who do not know they have been diagnosed with cancer The intervention and control groups were randomized according to the literature; taking into account age group, education status, type and stage of gynecological cancer. When determining the intervention and control groups, patients who applied to the chemotherapy unit on Monday and Tuesday were included in the intervention group, and patients who applied on Wednesday and Thursday were included in the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 27, 2024

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

June 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations