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临床试验/NCT07355946
NCT07355946已完成不适用

The Effect of Nurse-Led Coaching Program on Self-Care Agency and Quality of Life in Reconstructed Breast Cancer Patients

Gazi University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年2月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1

研究概览

简要总结

The primary objective of this clinical study is to examine the effects of a nurse-led coaching program on self-care agency and quality of life in patients who have undergone reconstructive surgery for breast cancer.

  1. Is there a difference in self-care agency between breast reconstructive patients who received a nurse-led coaching program and those who did not?
  2. Is there a difference in quality of life between breast reconstructive patients who received a nurse-led coaching program and those who did not?

The secondary objective of this clinical study is to determine the satisfaction levels of patients who participated in a nurse-led coaching program for breast reconstructive surgery. The secondary questions the study aims to answer are: 3. What is the satisfaction level of breast reconstructive patients who received a nurse-led coaching program?

The researchers will compare whether there are differences in self-care agency and quality of life between breast cancer patients who received a nurse-led coaching program (intervention group) and those who did not (control group).

Participants:

  • Patients who meet the inclusion criteria will be informed of the study's purpose during their postoperative hospital stay, and their informed consent will be obtained. Patients who agree to participate will complete an Introductory Information Form, the Self-Care Agency Scale, and the EORTC QLQ-C30 and QLQ-BR-42 Quality of Life Scales.
  • After completing the pre-test measurements, the researchers will randomly assign patients to either the control or intervention groups using a random number table.
  • Patients in the intervention group will receive a routine debriefing on the day of discharge and a total of nine coaching sessions, scheduled weekly for the first 6 weeks and biweekly for the following 6 weeks. These sessions will be conducted via online meeting.
  • Patients in the control group will receive a routine debriefing only on the day of discharge.
  • Post-test measurements will be administered to both groups at 12 weeks post-operatively.

详细描述

MATERIALS AND METHODS

  1. Research Method This study was planned as a randomized controlled experimental study to determine the effects of a nurse-led coaching program on self-care agency and quality of life in breast cancer patients undergoing reconstruction.
  2. Location and Characteristics of the Study The study is being conducted in 2025 at the Gazi University Health Research and Application Center (GUSAUM) Plastic Reconstructive and Hand Surgery Clinic and the Ankara Etlik City Hospital Plastic Surgery Clinic at Türkiye. In these clinics, breast reconstruction surgeries are performed simultaneously with breast cancer surgery, and in the early and late postoperative periods. Patients are admitted to the clinic the day before or on the day of surgery and undergo general anesthesia. Postoperative hospital stays are 1-3 days for patients undergoing breast reconstruction using breast implants, 3-4 days for patients undergoing TRAM flap reconstruction, and approximately 7-15 days for patients undergoing DIEP flap reconstruction. Apart from routine perioperative procedures, no special procedures are performed for breast reconstruction surgery at the clinic.

Patients return to the outpatient clinic for follow-up visits 1-2 weeks after discharge and at one month. At three months postoperatively, the non-reconstructed breast is evaluated for equality with the reconstructed breast, and decisions are made about additional interventions. For patients undergoing core tissue breast reconstruction, the nipple and areola are also reconstructed during this process. 3. Research Universe and Sample Selection The research universe consisted of patients who underwent breast reconstruction due to breast cancer at GUSAUM Plastic, Reconstructive, and Hand Surgery and Ankara Etlik City Hospital Plastic Surgery Clinic.

Inclusion criteria for the study were:

  • Patients who had undergone breast reconstruction surgery due to breast cancer,
  • Patients aged 18 and over,
  • Patients who understood and spoke Turkish,
  • Patients who agreed to participate voluntarily,
  • Patients who were literate.

Exclusion criteria included:

  • Patients with speech, hearing, or visual impairments,
  • Patients with a psychiatric diagnosis or ongoing treatment,
  • Patients with metastatic breast cancer,
  • Patients with a cancer diagnosis other than breast cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Data obtained from the intervention and control groups were coded as group one and group two in the SPSS program. During the statistical analysis of the data in the study, the intervention and control group data were masked, and the statistical analyses were performed by a different expert to ensure the statistician's blindness. The statistician had no information about which group the patients belonged to.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Having undergone breast reconstruction surgery due to breast cancer,
  • Being 18 years of age or older,
  • Being able to understand and speak Turkish,
  • Voluntarily agreeing to participate in the study,
  • Being able to read and write.

排除标准

  • Having a speech, hearing, or vision impairment,
  • Having a psychiatric diagnosis or ongoing treatment,
  • Having metastatic breast cancer,
  • Having a cancer diagnosis other than breast cancer.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevil Güler

Professor Doctor

Gazi University

研究点 (1)

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