Quality of LifeNCT05399160
Effect of Nurse-led Supportive Care on Quality of Life
A study testing Nurse-led Supportive Care in people with Quality of Life, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Nurse-led Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2022to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having communication problems
- Having psychological diseases
- Receiving any supportive care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Health Sciences Faculty
Izmir, 35560
About this study
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
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Nurse-led Supportive Care
- Keywords
- Nurse-led care, Quality of life, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Supportive CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led Supportive Care Group | Experimental | Not described Receives: Behavioral: Nurse-led Supportive Care |
| Control Group | No intervention | The control group did not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Quality of Life score at 9th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start3 Jan 2022
- Primary completion30 May 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Zorba Bahceli, PhD RN, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399160
- Sponsor's protocol ID
- 2021/270
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38433074
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05399160
- Acronym / sponsor ID
- 2021/270
- Conditions
- Quality of Life
- Keywords
- Nurse-led care, Quality of life, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led Supportive Care Group | Experimental | Behavioral: Nurse-led Supportive Care |
| Control Group | No intervention | –The control group did not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older women,
- Stages II or III breast cancer
- Having breast cancer surgery
- Planned to receive chemotherapy
- Able to use a phone
Key exclusion criteria (3 listed)
- Having communication problems
- Having psychological diseases
- Receiving any supportive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Supportive CareNurse-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. | Behavioural | Nurse-led Supportive Care Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 38433074Yazicioglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Supportive Care in people with Quality of Life, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.