Tele-nursing Practices Based on Technological Competence Theory in Breast Cancer Patients

NCT05998655 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/787
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a randomized controlled double-blind experimental study aiming to evaluate the effect of tele-nursing practices based on technological competence theory on empowerment status and symptom management self-efficacy in breast cancer patients. The research will be carried out between September 2023 and March 2024 with patients diagnosed with breast cancer, who are receiving chemotherapy on an active basis, registered in the Medical Oncology Polyclinic of Atatürk University Health Research and Application Center. The sample of the study will consist of 70 people, 35 of which are in the experimental group and 35 in the control group. Afterwards, approximately 11 weeks of tele-nursing practices, including training, counseling and tele-monitoring based on the theory of technological competence, will be given to the experimental group. While preparing the content of tele-nursing practices, national and international literature will be scanned. In line with the literature; Training, consultancy and follow-up will be provided on breast cancer, problems experienced in the treatment process of breast cancer, the most frequently experienced chemotherapy symptoms and management strategies. Before starting the training program, a training booklet will be distributed to the patients and shared as an e-booklet. Within the scope of the training program, a five-week training will be held once a week via "Google Meet". After the training program is completed, the counseling and telemonitoring process will begin. In this process, a previously prepared consultancy guide will be used. Counseling and telemonitoring will cover 2 chemotherapy cycles (approximately 6 weeks). Within the scope of the application, the entire experimental group will be individually phoned on the 7th day after receiving a chemotherapy course. Information about the individual conditions of the patients and the instant status changes regarding the symptoms will be obtained and their questions will be answered in line with the previously created counseling guide. Patients will be informed that at any time other than the specified days, the questions of the patients regarding the instantaneous situation changes will be answered. After the completion of the tele-nursing practices, post-test measurements will be made with the Cancer Empowerment Scale and the Chemotherapy Symptom Management in Breast Cancer-Self-efficacy Scale of the experimental and control groups, and the feedback of the patients in the experimental group regarding the implementation process will be received. No attempt will be made to the individuals in the control group during the research process. Keywords: Tele-nursing, Technological Competence Theory, Breast Cancer, Cancer Empowerment, Symptom Management

Conditions

Breast Cancer Female

Keywords

Tele-nursing; Technological Competence Theory; Breast Cancer; Cancer Empowerment; Symptom Management

Outcome Measures

Primary Outcomes (2)

• Cancer Empowerment Scale

  n 2013, Van den Berg et al. The 'Cancer Empowerment Scale', developed ., is a 40-item scale created to understand the empowerment of patients in coping with their diseases during their illness. It was adapted into Turkish by Karabulutlu, et al., (2021) and consists of 4 sub-dimensions: personal power, social support, health care and community. The total Cronbach's alpha coefficient of the scale is 0.93, and the increase in the total score and the mean score of the sub-dimensions indicates that the patients become stronger in this disease process.

  11 week

• Chemotherapy Symptom Management in Breast Cancer-Self-Efficacy Scale

  iang et al. (2015) Chemotherapy Symptom Management-Self-Efficacy Scale was developed to evaluate symptom management and self-efficacy in breast cancer patients undergoing chemotherapy. The scale, which was adapted into Turkish by Semiz D., and Sağlam R. (2018), consists of 3 sub-dimensions and 27 items: problem-solving skills, management of chemotherapy-related symptoms, and management of emotional-interpersonal problems. Items are scored on a 0-10 point likert scale (0 = not at all sure, 10 = very sure). The total score is obtained by adding the digits of each answer from the scale. The score for the entire scale ranges from 0 to 270. When calculating the scores on the scale items, a high score indicates that the person's perceived self-efficacy in managing symptoms is high

  11 week

Study Arms (2)

experimental group

EXPERIMENTAL

In the research, tele-nursing practices and counseling based on the theory of technological competence will be provided to the experimental group.

Other: tele nursing

control group

NO INTERVENTION

No attempt will be made on individuals in the control group during the research process

Interventions

tele nursing OTHER

In the research, tele-nursing applications based on technological competence theory will be applied to the experimental group. In the content of the application, training, consultancy and follow-up will be made on breast cancer, the problems experienced in the treatment process of breast cancer, the most frequently experienced chemotherapy symptoms and management strategies. Technology knowledge will be based on the concepts of collaborative design and participant interaction. A five-week group training will be implemented once a week. The training will be applied to all the participants in the experimental group and will be held over "Google Meet". Educational program; pre-prepared powerpoint presentations, oral narration, discussion and group training will be made using e-booklets.

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Breast cancer in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer I., II. or III. in phase
• Without organ metastases
• Those who have not been diagnosed with any other cancer other than breast cancer
• Literate
• Receiving neoadjuvant chemotherapy
• Received at least 1 course of chemotherapy
• Those who does not have hearing and speech problems that will prevent talking on the phone
• Capable of using a smartphone
• Does not have any psychiatric problems that reduce the ability to understand
• Who volunteered to participate in the research

You may not qualify if:

• With stage 4 breast cancer
• Organ metastases
• Those who have been diagnosed with a cancer other than breast cancer
• iliterate
• Cannot communicate verbally
• Unable to use a smartphone
• No internet connection or online access
• Who refused to participate in the research

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nisa YAVUZER BAYRAK

  Ataturk University

  PRINCIPAL INVESTIGATOR

• Elanur YILMAZ KARABULUTLU

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisa YAVUZER BAYRAK

CONTACT

5434391147; nisayavuzer@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the data collection process, double-blindness will be ensured by not specifying which group the interviewer collects data from and which group the participants are from.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Randomization will be made on a day-by-day basis due to the possibility of patients interacting in the outpatient clinic and waiting room during the research process. Before starting the research, a coin will be tossed to determine which group will be included on which day. If the money comes in summer, the patients who come on the first day will be taken to the experimental group, the patients who come on the second day will be taken to the control group. In the case of heads, the patients who come on the first day will be included in the control group, and the patients who come on the second day will be included in the experimental group.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

TU (1)