Breast CancerNCT04914780
The Effect of Training Given by Mobile Application to Women Undergoing Breast Surgery
A study testing Education in people with Breast Cancer, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
In a metanalysis study examining the effects of mobile health applications on the quality of life and psychological outcomes of patients with breast cancer, it was concluded that the quality of life increased, the level of self-efficacy was high, and the perceived stress, depression and anxiety were low compared to… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18 years of age and over,
- Breast Conserving Surgery is applied,
- Only diagnosed with breast cancer and not having metastases,
- Participating voluntarily in the research,
- Signed the informed consent form,
- Patients who have a smart phone on them or near them will be included in the study.
Who cannot join
- Not operated after the diagnosis of breast cancer and / or surgery other than Breast Conserving Surgery,
- Another type of cancer other than breast cancer,
- Having a disability to answer questions such as dementia, Alzheimer's, hearing and vision loss,
- Illiterate,
- Do not have a smart phone and / or do not know how to use it,
- Patients in the terminal period will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Medical Faculty Hospital Oncology Clinic
Konya
About this study
Official title: The Effect of Training Performed Using Mobile Application on Care Requirements and Quality of Life in Women With Breast Cancer: Randomized Controlled Trial
In a metanalysis study examining the effects of mobile health applications on the quality of life and psychological outcomes of patients with breast cancer, it was concluded that the quality of life increased, the level of self-efficacy was high, and the perceived stress, depression and anxiety were low compared to standard care. It has been stated that there is a need for well-designed randomized studies on the subject due to the heterogeneity of the study results. In a study examining the effects of exercise training given by mobile health application and traditional brochure on physical function, physical activity and quality of life in breast cancer patients, improvement was observed in both groups, but no significant difference was found between the groups. In the study conducted to evaluate the effect of the information transmitted via the mobile application on preoperative breast cancer patients, it was concluded that control patients who did not have access to additional information provided by the mobile application had significantly lower anxiety and depression scores at seven days before surgery compared to the intervention group, and thus, when less information was accessed. It has been reported that anxiety decreases. Surgical treatments applied to women with breast cancer, although there are different treatment options depending on the stage of the disease and the results of the diagnostic procedures; breast-conserving surgery (lumpectomy / tumorectomy, partial mastectomy, segmental mastectomy / quadranectomy) and non-breast-conserving surgery (simple mastectomy, bilateral mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, modified radical mastectomy, radical mastectomy). When the literature is examined; It was stated that negative emotions such as body image deterioration, decreased self-esteem, hopelessness, guilt, anxiety, and depression were experienced less in patients who underwent breast conserving surgery (BCS) compared to patients who received other breast surgical treatments. Compared to other patients, those who undergo BCS adapt better to the treatment and care process. There are some disadvantages for patients in BCS, which is preferred in the early stage, which aims to protect the integrity of the breast. Some of the disadvantages are the long-term treatment process, the expensive treatments and the difficult access for those living far from the radiotherapy treatment, which is mostly applied in large centers. In addition to these disadvantages, women experience intense psychosocial problems, symptoms experienced during the treatment process negatively affect their compliance with treatment and quality of life. In order to improve the affected quality of life, besides nursing interventions specially planned for each patient, trainings that will facilitate their adaptation to the disease during the diagnosis and treatment process should be planned.
Read the detailed description
Breast cancer patients have many problems from different treatment processes and care needs to be met. Determining and supporting care needs affects the quality of life of patients. It is known that training provided by mobile applications enables patients with breast cancer to cope easily with their problems and increase their quality of life. Health needs to be individualized by shifting from institution- and physician-centered understanding to individual-centered healthcare service provision. There is no study in the literature evaluating the results of the training given specific to the supportive care needs with mobile application after surgery. The use of the mobile application that allows patient-centered supportive care for the education given to the patients reveals the difference of this study as it also includes interactive training. Mobile application to be created from educational content for patients with breast cancer; It aims to meet the holistic health care needs of women and to increase the quality of life by determining the individual care needs of women in the period after BCS. In this context, it is thought that the aim of reducing the care needs of patients and increasing the quality of life can be achieved with the education given to the patients. The mobile application includes maintaining and improving the health of women with breast cancer and offering solutions based on the literature for the problems they experience. It will be determined what the unmet needs of women with breast cancer that arise in different treatment processes, to what extent this process affects the quality of life of women and what solutions can be offered for these needs. In addition, the advantages and disadvantages of the mobile application method will be determined, and its effect on the patients' supportive care needs and quality of life will be revealed. The findings to be obtained, besides contributing to the literature, will reveal the educational needs of women with breast cancer and guide the treatment and care practices aimed at improving the quality of life. In addition, we aim to contribute to the development of mobile applications in the field of health by sharing our experiences with mobile application preparation. The mobile application developed after the study will be made available to all women with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Education
- Keywords
- Breast Cancer, Mobil Application, Quality of life, supportive Care Requirements
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education intervention with mobile application for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 4 weeks training with mobile application Receives: Behavioral: Education |
| Control group | No intervention | No intervention will be made for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in supportive care needs at 4 weeks and 8 weeks
After the training given by the mobile application, the supportive care needs scores of the patients are checked.
It has been stated that the DBGÖ-SF is a measurement tool with sufficient validity and reliability indicators. Your scale; There are 9 items in the "spiritual / psychological" sub-dimension and the minimum score from this dimension is 9; maximum score is 45. There are 10 items in the "Health system and information dimension" and the minimum score obtained from this dimension is 10; maximum score is 50. There are 5 items in the "Physical and daily life" dimension and the minimum score obtained from this dimension is 5; maximum score is 25. There are 4 items in the "patient care and support" dimension and the minimum score obtained from this dimension is 4; maximum score is 20. There are 3 items in the "sexuality" dimension and the minimum score obtained from this dimension is 3; maximum score is 15.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (1)
Change from baseline in life quality at 4 weeks and 8 weeks
The quality of life scores of the patients are checked after the training given with the mobile application.
Each area is calculated over a maximum of 20 points or 100 points. Which of these ratings will be used depends on the researcher. Calculations over 20 points are more commonly used in our country. The higher the score on the scale, the higher the quality of life. The correlation coefficients of the scale range between 0.49 and 0.78 (14th and 17th questions). When the Cronbach's alpha values are defined as values reflecting the homogeneity of the question scores with the field scores, the internal consistency of the sections and fields of WHOQOL-BREF (TR) was found to be quite high.
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914780
- Sponsor's protocol ID
- KaratayUHaticeTEZ
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the research is over
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Performed Using Mobile Application on Care Requirements and Quality of Life in Women With Breast Cancer: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04914780
- Acronym / sponsor ID
- KaratayUHaticeTEZ
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Mobil Application, Quality of life, supportive Care Requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Jun 2021 (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.
In a metanalysis study examining the effects of mobile health applications on the quality of life and psychological outcomes of patients with breast cancer, it was concluded that the quality of life increased, the level of self-efficacy was high, and the perceived stress, depression and anxiety were low compared to standard care. It has been stated that there is a need for well-designed randomized studies on the subject due to the heterogeneity of the study results. In a study examining the effects of exercise training given by mobile health application and traditional brochure on physical function, physical activity and quality of life in breast cancer patients, improvement was observed in both groups, but no significant difference was found between the groups. In the study conducted to evaluate the effect of the information transmitted via the mobile application on preoperative breast cancer patients, it was concluded that control patients who did not have access to additional information provided by the mobile application had significantly lower anxiety and depression scores at seven days before surgery compared to the intervention group, and thus, when less information was accessed. It has been reported that anxiety decreases. Surgical treatments applied to women with breast cancer, although there are different treatment options depending on the stage of the disease and the results of the diagnostic procedures; breast-conserving surgery (lumpectomy / tumorectomy, partial mastectomy, segmental mastectomy / quadranectomy) and non-breast-conserving surgery (simple mastectomy, bilateral mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, modified radical mastectomy, radical mastectomy). When the literature is examined; It was stated that negative emotions such as body image deterioration, decreased self-esteem, hopelessness, guilt, anxiety, and depression were experienced less in patients who underwent breast conserving surgery (BCS) compared to patients who received other breast surgical treatments. Compared to other patients, those who undergo BCS adapt better to the treatment and care process. There are some disadvantages for patients in BCS, which is preferred in the early stage, which aims to protect the integrity of the breast. Some of the disadvantages are the long-term treatment process, the expensive treatments and the difficult access for those living far from the radiotherapy treatment, which is mostly applied in large centers. In addition to these disadvantages, women experience intense psychosocial problems, symptoms experienced during the treatment process negatively affect their compliance with treatment and quality of life. In order to improve the affected quality of life, besides nursing interventions specially planned for each patient, trainings that will facilitate their adaptation to the disease during the diagnosis and treatment process should be planned.
Detailed description
Breast cancer patients have many problems from different treatment processes and care needs to be met. Determining and supporting care needs affects the quality of life of patients. It is known that training provided by mobile applications enables patients with breast cancer to cope easily with their problems and increase their quality of life. Health needs to be individualized by shifting from institution- and physician-centered understanding to individual-centered healthcare service provision. There is no study in the literature evaluating the results of the training given specific to the supportive care needs with mobile application after surgery. The use of the mobile application that allows patient-centered supportive care for the education given to the patients reveals the difference of this study as it also includes interactive training. Mobile application to be created from educational content for patients with breast cancer; It aims to meet the holistic health care needs of women and to increase the quality of life by determining the individual care needs of women in the period after BCS. In this context, it is thought that the aim of reducing the care needs of patients and increasing the quality of life can be achieved with the education given to the patients. The mobile application includes maintaining and improving the health of women with breast cancer and offering solutions based on the literature for the problems they experience. It will be determined what the unmet needs of women with breast cancer that arise in different treatment processes, to what extent this process affects the quality of life of women and what solutions can be offered for these needs. In addition, the advantages and disadvantages of the mobile application method will be determined, and its effect on the patients' supportive care needs and quality of life will be revealed. The findings to be obtained, besides contributing to the literature, will reveal the educational needs of women with breast cancer and guide the treatment and care practices aimed at improving the quality of life. In addition, we aim to contribute to the development of mobile applications in the field of health by sharing our experiences with mobile application preparation. The mobile application developed after the study will be made available to all women with breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Education4 weeks training with mobile application |
| Control group | No intervention | –No intervention will be made for 4 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and over,
- Breast Conserving Surgery is applied,
- Only diagnosed with breast cancer and not having metastases,
- Participating voluntarily in the research,
- Signed the informed consent form,
Key exclusion criteria (6 listed)
- Not operated after the diagnosis of breast cancer and / or surgery other than Breast Conserving Surgery,
- Another type of cancer other than breast cancer,
- Having a disability to answer questions such as dementia, Alzheimer's, hearing and vision loss,
- Illiterate,
- Do not have a smart phone and / or do not know how to use it,
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 |
|---|---|---|
| EducationEducation intervention with mobile application for 4 weeks | Behavioural | Intervention group |
Primary outcome
Change from baseline in supportive care needs at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks and 8 weeks
After the training given by the mobile application, the supportive care needs scores of the patients are checked. It has been stated that the DBGÖ-SF is a measurement tool with sufficient validity and reliability indicators. Your scale; There are 9 items in the "spiritual / psychological" sub-dimension and the minimum score from this dimension is 9; maximum score is 45. There are 10 items in the "Health system and information dimension" and the minimum score obtained from this dimension is 10; maximum score is 50. There are 5 items in the "Physical and daily life" dimension and the minimum score obtained from this dimension is 5; maximum score is 25. There are 4 items in the "patient care and support" dimension and the minimum score obtained from this dimension is 4; maximum score is 20. There are 3 items in the "sexuality" dimension and the minimum score obtained from this dimension is 3; maximum score is 15.
1 secondary outcome
Change from baseline in life quality at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks and 8 weeks
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 9 Mar 2023.
- Individual participant dataSharing planned: No. After the research is over
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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 Education in people with Breast Cancer, run by KTO Karatay 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 6 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 9 Mar 2023. 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?
Change from baseline in supportive care needs at 4 weeks and 8 weeks (time frame: Baseline, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2023.