Web Based InterventionMastectomyNCT05222763

Web-Assisted Interactive Nurse Program in Mastectomy Patients: A Mixed Method Study

A study testing Web-assisted patient education intervention designed according to the self-regulation model and The website where the mastectomy patients handbook in people with Web Based Intervention and Mastectomy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Web Based Intervention, Mastectomy, Illness Perception
What is being tested?: Web-assisted patient education intervention designed according to the self-regulation model and The website where the mastectomy patients handbook
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 24 Aug 2022to 29 Aug 2023
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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients aged 18-75 who do not have communication problems,
Patients who have undergone mastectomy for the first time,
Patients who know their diagnosis,
Patients with basic computer literacy,
Patients with computer or internet access.
Patients who agree to participate in the study will be included.

Who cannot join

Patients with hearing, vision and understanding problems,
Patients with metastases
Patients with breast cyst excision,
Patients with arm or shoulder limitation,
Patients with breast reconstruction will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gaziosmanpasa University
Tokat Province, 60150

Other trials in Turkey (Türkiye)

About this study

Official title: Effect Of Web - Supported Interactıve Nursıng Program After Mastectomy On Body Value, Care Dependence And Psychosocıal Adaptatıon To Dısease-Self-Awareness Levels Accordıng To Self-Regulatıon Model: Mıxed Method Study

This study is planned to examine the levels of bodily value, care dependence and psychosocial cohesion-self-notification of patients in the Web Assisted Interactive Nursing Program (WDIHP) designed according to the Self Regulation Model. The mixed method is a research. One of the mixed research methods, the discovery sequenced design, will be used. The research will continue with the quantitative part, starting with the qualitative part. The quantitative part of the research is a randomized controlled experimental trial.

Read the detailed description

Complications after surgery are common in patients who undergo mastectomies, as in every surgery. Mastectomy patients need to protect the wound area and the arm on the side where a mastectomy is performed following surgery. The process of wound healing and return to the patient's daily life in the post-surgery process parallels. In the early post-operative period, patients have difficulty carrying out daily living activities and need support, while in the late-term they are able to perform daily living activities more independently from caregivers and nurses.

Objective: This research was planned to examine the body value of mastectomy patients, care dependence and psychosocial adaptation-self-knowledge levels of the Web Assisted Interactive Nursing Program (WDIHP) designed according to the Self-Regulation Model.

Method: The research is designed as a mixed-method study of qualitative-quantitative research methods, designed according to the Self-Regulation Model, to examine the effect of WDHP on adaptation to social life, self-efficacy, and body value in patients undergoing breast cancer surgery. This study will use exploratory hybrid methods from mixed research methods. Qualitative interviews will be held face-to-face. Interviews with participants will continue until data saturation is achieved. In the qualitative part of the research, the in-depth interview method will be selected and the "Semi-Structured Interview Form" will be used as a data collection tool. All interviews will be recorded in digital format, returned to writing and then transferred to qualitative analysis software MAXQDA. The quantitative part of the study will be carried out as a randomized controlled trial using the block randomization method. Randomization will be done by a statistician other than the researcher. Power analysis was calculated using G * Power 3.1.9.7 program. With 0.95 effect size, 95% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 67 individuals, 35 individuals in the intervention group and 31 individuals in the control group, by taking 15% more of the calculated sample against the possibility of sample loss during the study. The correct perceptions that may arise as a result of qualitative work will be supported in the relevant sections of the training. In the quantitative section of the research, the interactive web-assisted nurse program will take 1 week and the application will take 3 weeks. A text message will be sent to individuals to their phone to remind them to use the website. Messages will be sent twice a week, a total of 8 times. It will be used as Care Dependency, Body value, psychosocial Compliance to disease, website usability Scale measurement tools. After each assessment, the data obtained will be transferred to the "Social Sciences Software Statistical Package (SPSS).

Conditions: Web Based Intervention, Mastectomy, Illness Perception, Nursing Caries
Being tested: Web-assisted patient education intervention designed according to the self-regulation model, The website where the mastectomy patients handbook
Keywords: Mastectomy, body value, adaptation to illness, care addiction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web-assisted patient education intervention designed according to the self-regulation modelBehavioural
Implementation of patient education with the website created about care and compliance needs in mastectomy patients obtained as a result of qualitative research.
The website where the mastectomy patients handbookBehavioural
The site where the patient booklet is available as pdf

Study groups in NCT05222763
Study group	Role	What they receive
Experimental: Interventional group	Experimental	The web-supported interactive nursing program intervention will take 3 weeks. The first week of the training will begin with the patient's admission to the clinic. Shoulder and Arm Exercises, Lymphedema in the Arm and Prevention of Its Development, and qualitative study, the themes of misperception determined in this area will be emphasized. In the second week, they will be asked to continue their Shoulder and Arm Exercises training, to examine the Other Side Breast Examination Training and Adaptation Process to Life Activities, Skin Care and Post-Surgery Cancer Treatment and Breast Reconstruction. In the last week of the training, it will be requested to review the contents again. Correct perceptions that may emerge as a result of the qualitative study will be supported in the relevant parts of the training. During the study, short mobile phone messages containing reminders and motivations will be sent regularly twice a week (8 times). Receives: Behavioral: Web-assisted patient education intervention designed according to the self-regulation model
Behavioral:	Active comparator	The handbook developed within the scope of the "Women's Return to Social Life After Mastectomy" Project on the website of the Continuing Education, Research and Solidarity Association will be used on the website of the participants assigned to the control group. Receives: Behavioral: The website where the mastectomy patients handbook

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Appreciation Scale
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items.There is no reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Measured: Before application
Care Dependency Scale
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Measured: Before application
Psychosocial Adjustment to Illness-Self-Report Scale
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.
The scale consists of 46 items. The questions in the scale are divided into 7 areas of psychosocial adjustment to the disease.
In the scale, four descriptive expressions were used to determine the varying levels of agreement for each question. The subject can choose the answer that best describes his or her personal experience. The items in the scale are given scores ranging from 0 to 3, and the answers are converted into numerical values. For each item in the scale, mostly negative changes since the disease are evaluated with 3 points, no change or positive changes are evaluated with 0 points. Low scores on the PAIS-SR scale indicate "good psychosocial adjustment" to the disease, and high scores indicate "poor psychosocial adjustment" to the disease. In the PAIS-SR, scores below 35 indicate "good psychosocial adjustment", scores between 35 and 51 indicate
Measured: Before application
Body Appreciation Scale
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items.There isno reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Measured: Immediately after application (1st week)
Care Dependency Scale
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Measured: Immediately after application (1st week)
Psychosocial Adjustment to Illness-Self-Report Scale
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.
Measured: Immediately after application (1st week)
Body Appreciation Scale
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items.
There is no reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Measured: Immediately after application (3st week)
Care Dependency Scale
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Measured: Immediately after application (3st week)
Psychosocial Adjustment to Illness-Self-Report Scale
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.
Measured: Immediately after application (3st week)

Secondary outcomes (1)

Website Usability Scale
The scale consists of a total of 25 questions with four sub-dimensions (ease of navigation = 10 questions, design = 7 questions, ease of access = 4 questions, ease of use = 4 questions). The answers to the items of the scale are collected with a Likert-type five-point rating scale. The scale consists of "Strongly agree (5)", "Agree (4)", "Undecided (3)", "Disagree (2)" and "Strongly disagree (1)". 21 of the items in the scale are positive and 4 of them are negative items. The lowest score to be taken from the scale is 25 and the highest score is 125.
Measured: Immediately after application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202229 Aug 2023

First posted3 Feb 2022
Study start24 Aug 2022
Primary completion24 Apr 2023
Study completion29 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (82)Papers the sponsor has linked to this study.
Other trials for Web Based InterventionStudies 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05222763
Sponsor's protocol ID: 939597
Acronym: Mastectomy
Status last verified: Aug 2023
First submitted: 24 Jan 2022
Last updated: 31 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ab Malik N, Zhang J, Lam OL, Jin L, McGrath C. Effectiveness of computer-aided learning in oral health among patients and caregivers: a systematic review. J Am Med Inform Assoc. 2017 Jan;24(1):209-217. doi: 10.1093/jamia/ocw045. Epub 2016 Jun 6.
PubMed 27274013
Adaylar M. Kronik hastalığı olan bireylerin hastalıktaki tutum, adaptasyon, algı ve öz-bakım yönelimleri. İstanbul Üniversitesi Sağlık Bilimleri Enstitüsü, Hemşirelik Anabilim Dalı, Doktora tezi, İstanbul, 1995
Ahadzadeh AS, Sharif SP. Uncertainty and Quality of Life in Women With Breast Cancer: Moderating Role of Coping Styles. Cancer Nurs. 2018 Nov/Dec;41(6):484-490. doi: 10.1097/NCC.0000000000000552.
PubMed 29489477
Anderson C, Islam JY, Elizabeth Hodgson M, Sabatino SA, Rodriguez JL, Lee CN, Sandler DP, Nichols HB. Long-Term Satisfaction and Body Image After Contralateral Prophylactic Mastectomy. Ann Surg Oncol. 2017 Jun;24(6):1499-1506. doi: 10.1245/s10434-016-5753-7. Epub 2017 Jan 5.
PubMed 28058563
Akyolcu, N., Özhanlı Y., Kandemir D. (2019). Meme Kanserinde Güncel Gelişmeler. Sağlık Bilimleri ve Meslek Dergisi, 6(3), 583-94.
Ayar, D., Öztürk, C. (2015). Tip 1 Diyabetik Ergenlerin Eğitiminde Yeni Yaklaşımlar Web Tabanlı Eğitim. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 8 (3),184-189.
Baysan Arabacı, L., Büyükbayram, A., Aktaş, Y., & Taşkın, N. (2018). Kronik ruhsal bozukluk tanısı alan hastaların bakım verenlerine verilen psikoeğitimin yaşadıkları güçlük ve psikososyal uyumlarına etkisi. Psikiyatri Hemşireliği Dergisi, 9(3), 175-185.
Borosund E, Cvancarova M, Moore SM, Ekstedt M, Ruland CM. Comparing effects in regular practice of e-communication and Web-based self-management support among breast cancer patients: preliminary results from a randomized controlled trial. J Med Internet Res. 2014 Dec 18;16(12):e295. doi: 10.2196/jmir.3348.
PubMed 25525672
Charnock D, Shepperd S, Needham G, Gann R. DISCERN: an instrument for judging the quality of written consumer health information on treatment choices. J Epidemiol Community Health. 1999 Feb;53(2):105-11. doi: 10.1136/jech.53.2.105.
PubMed 10396471
Chow KM, So WKW, Choi KC, Chan CWH. Sexual function, psychosocial adjustment to illness, and quality of life among Chinese gynaecological cancer survivors. Psychooncology. 2018 Apr;27(4):1257-1263. doi: 10.1002/pon.4663. Epub 2018 Mar 1.
PubMed 29430767
Classen CC, Chivers ML, Urowitz S, Barbera L, Wiljer D, O'Rinn S, Ferguson SE. Psychosexual distress in women with gynecologic cancer: a feasibility study of an online support group. Psychooncology. 2013 Apr;22(4):930-5. doi: 10.1002/pon.3058. Epub 2012 Feb 28.
PubMed 22374732
Creswell, J. W., & Plano Clark, V. L. (2018). Designing and conducting mixed methods research. In (3 rd. ed.).
Çakmak, E. K., Güneş, E., Çiftçi, S., & Üstündağ, M. T. (2011). Web Sitesi Kullan ı labilirlik Ölçe ğ inin Geli ş tirilmesi : Geçerlik , Güvenirlik Analizi ve Uygulama Sonuçlar ı Developing a Web Site Usability Scale : The Validity and Reliability Analysis & Implementation Results Giri ş. Pegem Eğitim ve Öğretim Dergisi, 1(2), 31-40.
Çam, O., Saka, Ş., & Gümüş, A. B. (2009). Meme Kanserli Hastaların Psikososyal Uyumlarını Etkileyen Faktörlerin İncelenmesi. Meme Sagligi Dergisi/Journal of Breast Health, 5(2).
Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12.
PubMed 28401542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect Of Web - Supported Interactıve Nursıng Program After Mastectomy On Body Value, Care Dependence And Psychosocıal Adaptatıon To Dısease-Self-Awareness Levels Accordıng To Self-Regulatıon Model: Mıxed Method Study
ClinicalTrials.gov ID: NCT05222763
Acronym / sponsor ID: Mastectomy / 939597
Conditions: Web Based Intervention, Mastectomy, Illness Perception, Nursing Caries
Keywords: Mastectomy, body value, adaptation to illness, care addiction
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Cumhuriyet UniversityUniversity, hospital or other
Study start: 24 Aug 2022 (actual)
Primary completion: 24 Apr 2023 (actual)
Study completion: 29 Aug 2023 (actual)
First posted: 3 Feb 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental: Interventional group	Experimental	Behavioral: Web-assisted patient education intervention designed according to the self-regulation modelThe web-supported interactive nursing program intervention will take 3 weeks. The first week of the training will begin with the patient's admission to the clinic. Shoulder and Arm Exercises, Lymphedema in the Arm and Prevention of Its Development, and qualitative study, the themes of misperception determined in this area will be emphasized. In the second week, they will be asked to continue their Shoulder and Arm Exercises training, to examine the Other Side Breast Examination Training and Adaptation Process to Life Activities, Skin Care and Post-Surgery Cancer Treatment and Breast Reconstruction. In the last week of the training, it will be requested to review the contents again. Correct perceptions that may emerge as a result of the qualitative study will be supported in the relevant parts of the training. During the study, short mobile phone messages containing reminders and motivations will be sent regularly twice a week (8 times).
Behavioral:	Active comparator	Behavioral: The website where the mastectomy patients handbookThe handbook developed within the scope of the "Women's Return to Social Life After Mastectomy" Project on the website of the Continuing Education, Research and Solidarity Association will be used on the website of the participants assigned to the control group.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients aged 18-75 who do not have communication problems,
Patients who have undergone mastectomy for the first time,
Patients who know their diagnosis,
Patients with basic computer literacy,
Patients with computer or internet access.

Key exclusion criteria (5 listed)

Patients with hearing, vision and understanding problems,
Patients with metastases
Patients with breast cyst excision,
Patients with arm or shoulder limitation,
Patients with breast reconstruction will not be included in the study.

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
Web-assisted patient education intervention designed according to the self-regulation modelImplementation of patient education with the website created about care and compliance needs in mastectomy patients obtained as a result of qualitative research.	Behavioural	Experimental: Interventional group
The website where the mastectomy patients handbookThe site where the patient booklet is available as pdf	Behavioural	Behavioral:

Primary outcome

Body Appreciation Scale
Time frame: Before application
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items.There is no reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Care Dependency Scale
Time frame: Before application
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Psychosocial Adjustment to Illness-Self-Report Scale
Time frame: Before application
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment. The scale consists of 46 items. The questions in the scale are divided into 7 areas of psychosocial adjustment to the disease. In the scale, four descriptive expressions were used to determine the varying levels of agreement for each question. The subject can choose the answer that best describes his or her personal experience. The items in the scale are given scores ranging from 0 to 3, and the answers are converted into numerical values. For each item in the scale, mostly negative changes since the disease are evaluated with 3 points, no change or positive changes are evaluated with 0 points. Low scores on the PAIS-SR scale indicate "good psychosocial adjustment" to the disease, and high scores indicate "poor psychosocial adjustment" to the disease. In the PAIS-SR, scores below 35 indicate "good psychosocial adjustment", scores between 35 and 51 indicate
Body Appreciation Scale
Time frame: Immediately after application (1st week)
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items.There isno reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Care Dependency Scale
Time frame: Immediately after application (1st week)
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Psychosocial Adjustment to Illness-Self-Report Scale
Time frame: Immediately after application (1st week)
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.
Body Appreciation Scale
Time frame: Immediately after application (3st week)
It was developed in order to evaluate the extent to which individuals have positive thoughts about their own bodies and whether they respect these thoughts. Body Value Scale-2 is a 5-point Likert type measurement tool and consists of 10 items. There is no reverse item in the Body Value Scale and a minimum of 10 and a maximum of 50 points can be obtained from the scale. A total score is obtained by summing the scores of the items in the scale. A low score from the scale indicates that individuals have negative body values, while high scores indicate positive body values.
Care Dependency Scale
Time frame: Immediately after application (3st week)
The care dependency scale is a scale consisting of a total of 17 items, including activities of daily living, and graded with 5-point Likert-type scoring. Grading 1 = completely dependent, 5 = immediately, immediately / completely independent. The lowest score to be taken from the scale is 17 and the highest score is 85. A high scale score indicates that the patient is independent in meeting his/her self-care needs, while a low scale score indicates that patients are dependent on others to meet their care needs.
Psychosocial Adjustment to Illness-Self-Report Scale
Time frame: Immediately after application (3st week)
It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.

1 secondary outcome

Website Usability Scale
Time frame: Immediately after application

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 31 Aug 2023.
Background: PubMed 27274013Ab Malik N, Zhang J, Lam OL, Jin L, McGrath C. Effectiveness of computer-aided learning in oral health among patients and caregivers: a systematic review. J Am Med Inform Assoc. 2017 Jan;24(1):209-217. doi: 10.1093/jamia/ocw045. Epub 2016 Jun 6.
BackgroundAdaylar M. Kronik hastalığı olan bireylerin hastalıktaki tutum, adaptasyon, algı ve öz-bakım yönelimleri. İstanbul Üniversitesi Sağlık Bilimleri Enstitüsü, Hemşirelik Anabilim Dalı, Doktora tezi, İstanbul, 1995
Background: PubMed 29489477Ahadzadeh AS, Sharif SP. Uncertainty and Quality of Life in Women With Breast Cancer: Moderating Role of Coping Styles. Cancer Nurs. 2018 Nov/Dec;41(6):484-490. doi: 10.1097/NCC.0000000000000552.
Background: PubMed 28058563Anderson C, Islam JY, Elizabeth Hodgson M, Sabatino SA, Rodriguez JL, Lee CN, Sandler DP, Nichols HB. Long-Term Satisfaction and Body Image After Contralateral Prophylactic Mastectomy. Ann Surg Oncol. 2017 Jun;24(6):1499-1506. doi: 10.1245/s10434-016-5753-7. Epub 2017 Jan 5.
BackgroundAkyolcu, N., Özhanlı Y., Kandemir D. (2019). Meme Kanserinde Güncel Gelişmeler. Sağlık Bilimleri ve Meslek Dergisi, 6(3), 583-94.
BackgroundAyar, D., Öztürk, C. (2015). Tip 1 Diyabetik Ergenlerin Eğitiminde Yeni Yaklaşımlar Web Tabanlı Eğitim. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 8 (3),184-189.
BackgroundBaysan Arabacı, L., Büyükbayram, A., Aktaş, Y., & Taşkın, N. (2018). Kronik ruhsal bozukluk tanısı alan hastaların bakım verenlerine verilen psikoeğitimin yaşadıkları güçlük ve psikososyal uyumlarına etkisi. Psikiyatri Hemşireliği Dergisi, 9(3), 175-185.
Background: PubMed 25525672Borosund E, Cvancarova M, Moore SM, Ekstedt M, Ruland CM. Comparing effects in regular practice of e-communication and Web-based self-management support among breast cancer patients: preliminary results from a randomized controlled trial. J Med Internet Res. 2014 Dec 18;16(12):e295. doi: 10.2196/jmir.3348.
Background: PubMed 10396471Charnock D, Shepperd S, Needham G, Gann R. DISCERN: an instrument for judging the quality of written consumer health information on treatment choices. J Epidemiol Community Health. 1999 Feb;53(2):105-11. doi: 10.1136/jech.53.2.105.
Background: PubMed 29430767Chow KM, So WKW, Choi KC, Chan CWH. Sexual function, psychosocial adjustment to illness, and quality of life among Chinese gynaecological cancer survivors. Psychooncology. 2018 Apr;27(4):1257-1263. doi: 10.1002/pon.4663. Epub 2018 Mar 1.
Background: PubMed 22374732Classen CC, Chivers ML, Urowitz S, Barbera L, Wiljer D, O'Rinn S, Ferguson SE. Psychosexual distress in women with gynecologic cancer: a feasibility study of an online support group. Psychooncology. 2013 Apr;22(4):930-5. doi: 10.1002/pon.3058. Epub 2012 Feb 28.
BackgroundCreswell, J. W., & Plano Clark, V. L. (2018). Designing and conducting mixed methods research. In (3 rd. ed.).
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.

Şeyda KAZANÇ, Lecturer principal investigator

Cumhuriyet University

Şerife KARAGÖZOĞLU, Prof. Dr. study director

Cumhuriyet University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 31 Aug 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?

Body Appreciation Scale (time frame: Before application). The study lists 9 primary outcomes in all. 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 NCT05222763, which also lists 82 linked publications.

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 31 Aug 2023.