Effect of Nurse-led Supportive Care on Quality of Life
June 29, 2022 updated by: Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
Effect of Nurse-led Supportive Care on Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Breast cancer is the most common type of cancer in women with a high mortality rate in the world.
The several methods are used in the treatment of breast cancer.
One or more of these methods can be preferred according to the characteristics of women with breast cancer.
Women may experience many different physiological and psychological symptoms during each treatment process.This situation negatively affects the quality of life of women with breast cancer.
For this reason, there is a need for an intervention that could improve quality of life in women with breast cancer.
In the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer.
This trial was conducted in the general surgery clinic of training and research hospital located in Turkey.
All patients were women who had breast surgery.
Study Type
Interventional
Enrollment (Actual)
42
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 Locations
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Izmir, Turkey, 35560
- Izmir Bakircay University Health Sciences Faculty
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18 years and older women,
- Stages II or III breast cancer
- Having breast cancer surgery
- Planned to receive chemotherapy
- Able to use a phone
- Who agreed to participate in the study
Exclusion Criteria:
- Having communication problems
- Having psychological diseases
- Receiving any supportive care
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Nurse-led Supportive Care Group
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Nurse-led supportive care was given to women who had breast surgery and planned to receive chemotherapy.
Nurse-led supportive care was applied to women for eight weeks in the form of face-to-face clinic and telephone interviews.It took an average of 30 minutes to interview women with breast cancer at the clinic, and 15 minutes on average by phone.
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No Intervention: Control Group
The control group did not receive any intervention during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)
Time Frame: Change from Baseline Quality of Life score at 9th weeks.
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The scale was developed to assess the quality of life of cancer patients.
It contains three domains that measure global health status/quality of life, functional and symptom status.
Global quality of life is assessed using global health status and quality of life.
Functional status consists of the following five subscales: physical function, role function, emotional function, cognitive function and social function.
Symptom status consists of the following nine subscales: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties.
The total score that can be obtained from the scale ranges from 0 to 100.
The internal consistency of scale in the Turkish version was determined as 0.90.
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Change from Baseline Quality of Life score at 9th weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 3, 2022
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
June 10, 2022
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
May 28, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
June 30, 2022
Last Update Submitted That Met QC Criteria
June 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021/270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.