Effectiveness of Nurse-Led Psychosocial Intervention (NLPI) on Quality of life, Depression, and Anxiety among women with breast cancer in a selected hospital of East Sikkim: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1. Quality of life with Functional Assessment of Cancer therapy -Breast FACT B
研究概览
简要总结
This study will develop and validate the Nurse led Psychosocial Interventions after extensive review and conducting Focus Group Discussion among healthcare providers and caregiver of breast cancer patients. The female breast cancer patients will be recruited and they will be randomized into intervention group and control group .The developed Nurse led psychosocial interventions module will be given to intervention group in five sessions (one session per week) and then follow up at 6th ,9th and 12th week . Then telephonic follow up will be done every twice a week for about 20 minutes till 6 months. The control group will be given standard care and general information booklet regarding cancer treatment , managing side effects of chemotherapy and stress management.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •With a confirmed diagnosis of non-metastatic breast cancer Admitted to the oncology ward STNM and undergoing 1st or 2nd cycle of chemotherapy Who are in stages II, III of breast cancer Who do not have any other chronic illness such as Chronic Kidney disease ,Chronic Liver disease, Chronic Obstructive Pulmonary Disease and Cerebrovascular accident Ability to speak and understand either English, Hindi, Nepali and willingly consented to attend all therapy sessions, Who are residing in the Gangtok District, Pakyong District and Mangan District Who have received the education upto Class 10 Who have scored more than 2 in Hospital Anxiety and Depression Scale.
排除标准
- •Those who have participated in MBSR, JPMR courses over the past six months, Diagnosed with Psychiatric disorders, Pregnant women with breast cancer, Witnessed adverse life events, including the death of family members, divorce, and spouse abandonment that occurred during the study or the past 6 months, Who have difficulty understanding the questionnaire or to communicate.
结局指标
主要结局
1. Quality of life with Functional Assessment of Cancer therapy -Breast FACT B
时间窗: Time points will be at baseline, after intervention at 1 week , 6 week, 9 week and 12 weeks
2.Depression and Anxiety with Hospital and anxiety HADS scale
时间窗: Time points will be at baseline, after intervention at 1 week , 6 week, 9 week and 12 weeks
次要结局
未报告次要终点
研究者
Nazung Lepcha
Sikkim Manipal College of Nursing, Sikkim Manipal Institute of Medical Sciences