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

Sponsor
Cumhuriyet University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05222763
Collaborator
(none)
67
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web-assisted patient education intervention designed according to the self-regulation model
  • Behavioral: The website where the mastectomy patients handbook
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
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.
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Aug 24, 2022
Anticipated Primary Completion Date :
Dec 24, 2022
Anticipated Study Completion Date :
Apr 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Interventional group

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

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
The site where the patient booklet is available as pdf

Outcome Measures

Primary Outcome Measures

  1. Body Appreciation Scale [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.

  2. Care Dependency Scale [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.

  3. Psychosocial Adjustment to Illness-Self-Report Scale [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

  4. Body Appreciation Scale [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.

  5. Care Dependency Scale [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.

  6. Psychosocial Adjustment to Illness-Self-Report Scale [Immediately after application (1st week)]

    It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.

  7. Body Appreciation Scale [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.

  8. Care Dependency Scale [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.

  9. Psychosocial Adjustment to Illness-Self-Report Scale [Immediately after application (3st week)]

    It measures the interaction of individuals with other individuals and institutions that make up the sociocultural environment.

Secondary Outcome Measures

  1. Website Usability Scale [Immediately after application]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziosmanpasa University Tokat Turkey 60150

Sponsors and Collaborators

  • Cumhuriyet University

Investigators

  • Principal Investigator: Şeyda KAZANÇ, Lecturer, Cumhuriyet University
  • Study Director: Şerife KARAGÖZOĞLU, Prof. Dr., Cumhuriyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Şeyda KAZANÇ, Lecturer, Cumhuriyet University
ClinicalTrials.gov Identifier:
NCT05222763
Other Study ID Numbers:
  • 939597
First Posted:
Feb 3, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Şeyda KAZANÇ, Lecturer, Cumhuriyet University
Mastectomy
body value
adaptation to illness
care addiction

Study Results

No Results Posted as of Jul 29, 2022