Effect of Nurse-led Supportive Care on Quality of Life
1 other identifier
interventional
42
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Jan 2022
Shorter than P25 for not_applicable quality-of-life
1 active site
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
January 3, 2022
CompletedFirst Submitted
Initial submission to the registry
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2022
CompletedJune 30, 2022
June 1, 2022
5 months
May 24, 2022
June 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Nurse-led Supportive Care Group
EXPERIMENTALControl Group
NO INTERVENTIONThe control group did not receive any intervention during the study period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having communication problems
- Having psychological diseases
- Receiving any supportive care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Izmir Bakircay University Health Sciences Faculty
Izmir, 35560, Turkey (Türkiye)
Related Publications (1)
Yazicioglu Kucuk B, Zorba Bahceli P. The Effects of Nurse-Led Supportive Care Program on Quality of Life in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Randomized Controlled Pilot Study. Semin Oncol Nurs. 2024 Apr;40(2):151609. doi: 10.1016/j.soncn.2024.151609. Epub 2024 Mar 2.
PMID: 38433074DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asistant Professor
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 1, 2022
Study Start
January 3, 2022
Primary Completion
May 30, 2022
Study Completion
June 10, 2022
Last Updated
June 30, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share