跳至主要内容
临床试验/NCT05873296
NCT05873296已完成不适用

Impact of Health Education on Lifestyle for Women With Breast Cancer: Health Education

Federal University of Maranhao2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Life habits

研究概览

简要总结

The sedentary lifestyle in women with breast cancer generates a problem for public health. An alternative that has been used to reduce sedentary behavior are interventions with the use of information technology, as well as projects with health education can cause lifestyle changes. However, little is known about the effect of these interventions on self-awareness and self-care in women with breast cancer. This aim of study is evaluate the effect of health education on sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength in women with breast cancer. This is a study the 12 weeks, with patients being treated for breast cancer, distributed for two groups: Group Health Education Recommendations and Control Group.

详细描述

This is a clinical trial with patients being treated for breast cancer, the sample will be randomly distributed into two groups: Group Health Education Recommendations (GRES) and Control Group (CG), which will remain in usual care. The intervention will last for 12 weeks, where GRES will receive health education recommendations in person and via social media. The endpoints of this study are sedentary behavior, lifestyle, physical activity level, nutrition, self-esteem, anxiety and depression, quality of life, pain, functional capacity, and strength. Evaluations will be performed at baseline, after 6 weeks, and after 12 weeks. Data will be analyzed by multivariate, comparing the effects of group, time, and interaction in SPSS software version 24.0, with α=5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 18 years or older;
  • Diagnosed with breast cancer;
  • Ongoing breast cancer treatment (chemotherapy, radiotherapy and/or hormone therapy);
  • Have daily access to a smartphone.

排除标准

  • Women having another type of cancer;
  • Perform physical training for three months before the intervention;
  • Has medical contraindication to perform any type of physical activity;
  • Have filled in yes on the PAR-Q and medical contraindication;
  • Without cognitive conditions to use a smartphone or answer questionnaires;
  • Illiterate women.

结局指标

主要结局

Life habits

时间窗: Change from baseline, 6 weeks Life habits at 12 weeks

Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire (score 0 to 3 - higher score is better)

Life habits

时间窗: Change from baseline, 6 weeks Life habits at 12 weeks

Lifestyle will be evaluated by Individual Lifestyle Profile Questionnaire (score 0 to 3 - higher score is better)

次要结局

  • Dimensions the quality of Life from cancer(Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks)
  • Level the pain(Change from baseline, 6 weeks Level the pain at 12 weeks)
  • Sitting time(Change from baseline, 6 weeks Sitting time at 12 weeks)
  • Body composition (lean mass, fat mass)(Change from baseline, 6 weeks Body composition at 12 weeks)
  • Time and level the physical activity(Change from baseline, 6 weeks Time and level the physical activity at 12 weeks)
  • Dimensions the quality of Life from breast cancer(Change from baseline, 6 weeks Dimensions the quality of Life at 12 weeks)
  • Eating habits(Change from baseline, 6 weeks Eating habits at 12 weeks)
  • Level the self-esteem(Change from baseline, 6 weeks Level the self-esteem at 12 weeks)

研究者

发起方
Federal University of Maranhao
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andréa Dias Reis

Principal Investigator

Federal University of Maranhao

研究点 (2)

Loading locations...

相似试验