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

NCT05222763 | Completed DMC

• 1 other identifier: 939597
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Web Based Intervention; Mastectomy; Illness Perception; Nursing Caries

Keywords

Mastectomy; body value; adaptation to illness; care addiction

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  Immediately after application (3st week)

Secondary Outcomes (1)

• Website Usability Scale

  Immediately after application

Study Arms (2)

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).

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.

Behavioral: The website where the mastectomy patients handbook

Interventions

Web-assisted patient education intervention designed according to the self-regulation model BEHAVIORAL

Implementation of patient education with the website created about care and compliance needs in mastectomy patients obtained as a result of qualitative research.

Experimental: Interventional group

The website where the mastectomy patients handbook BEHAVIORAL

The site where the patient booklet is available as pdf

Behavioral:

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60150, Turkey (Türkiye)

Location

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Study Officials

• Şeyda KAZANÇ, Lecturer

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

• Şerife KARAGÖZOĞLU, Prof. Dr.

  Cumhuriyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients participating in the study will know that they are in a randomized controlled study, but they will not know which group they are in until the study is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: August 24, 2022
• Primary Completion: April 24, 2023
• Study Completion: August 29, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)