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临床试验/CTRI/2026/03/105883
CTRI/2026/03/105883尚未招募不适用

A Randomised Control Trial (RCT) to assess the effectiveness of Breast Cancer Self- Care Chronicle (BCSCC) among Breast Cancer patients in improving Self-Care Management and recognition of Red-Flag Symptom after Breast Cancer Surgery in Surgical Oncology Ward at AIIMS Delhi.

not applicable1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1

研究概览

简要总结

A randomised controlled trial will be conducted among 100 women undergoing breast conserving surgery or mastectomy with or without axillary procedure in surgical oncology ward BRAIRCH AIIMS New Delhi to evaluate the effectiveness of Breast Cancer Self Care Chronicle which is a printable nurse delivered self care chronicle used for 4 weeks postoperatively. The intervention includes daily logs for wound and drain care, arm exercises, sleep, diet, hygiene and pictorial red flag prompts to support self care management and early recognition of warning symptoms.

Primary objectives are to compare self -care management and recognition or early reporting of red flag symptoms between experiment and control groups. secondary objectives are to assess incidence of follow up or readmission due to red flag symptoms in intervention group, effects on eligible participants are women above 18 years with histologically confirmed breast cancer undergoing definitive surgery , able to understand hindi or english or local language, owning reconstruction, significant cognitive or psychiatric or communication issues without caregiver , and palliative surgery or advanced disease.

Simple randomization will allocate participants to intervention. BCSCC and usual care will be provided to intervention group while only usual care will be given to control group. Data collection tool are developed by researcher and are under expert validation.Ethical approval, informed consent, and anonymity will be ensured. Pilot study will be done on 10 patients. Data will be analyzed using descriptive and inferential statistics.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Women aged 18 years and above
  • Histologically confirmed breast cancer undergoing definitive surgery (Breast-Conserving Surgery or Modified Radical Mastectomy, with or without axillary procedure)
  • Able to read or understand Hindi/English or local language.
  • Possession of a mobile phone for telephonic follow-up.
  • Willingness to provide informed consent and participate throughout the study duration.

排除标准

  • Patients undergoing immediate whole breast reconstruction (autologous or implant-based).
  • Patients with known cognitive impairment, psychiatric illness, or communication barriers without a responsible caregiver
  • Patients undergoing palliative surgery or with advanced disease where long-term self-care goals are not applicable.

研究者

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

Indu Dahiya

College of Nursing, AIIMS Delhi

研究点 (1)

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