Effect of Nurse-led Supportive Care on Quality of Life

Quality of Life Clinical Trial

Official title:

Effect of Nurse-led Supportive Care on Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399160
• Other study ID #: 2021/270
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: June 2022
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 10, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Nurse-led Supportive Care
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.

Locations

Country	Name	City	State
Turkey	Izmir Bakircay University Health Sciences Faculty	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Bakircay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)	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.	Change from Baseline Quality of Life score at 9th weeks.