Efficacy of a Web-based Self-management Exercise and Diet Intervention Program With Tailored Motivation and Action Planning for Breast Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Change from baseline in numbers of goal behaviors at 3 months
研究概览
简要总结
Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.
Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.
Hypotheses were following:
- Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.
- The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.
- The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.
- The intervention group will show a better HRQOL level compared to the control group.
- The intervention group will show a better self-efficacy level compared to the control group.
- The intervention group will show a lower fatigue level compared to the control group.
- The intervention group will show less anxiety compared to the control group.
- The intervention group will show less depression compared to the control group.
详细描述
The purpose of the study was to develop a web-based, stage-matched Exercise and Diet Planning program and to examine effects of the program on implementation of exercise and diet, self-efficacy, HRQOL, fatigue, anxiety and depression among breast cancer survivors.
All participants were recruited from two tertiary university hospitals and the National Cancer Center in Korea.
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 years and older
- •Histologically confirmed stage 0 to III breast cancer who received curative breast cancer surgery within 12 months since completion of primary cancer treatment and 2 years since diagnosis
- •Serum platelet ≥ 100,000/mm3
- •Serum hemoglobin ≥ 10g/dl
- •Not met one or more behavior goals: i) energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week; ii) intake of vegetables except kimchi ≥ 5 serv/day and intake of fruit 1-2 serv/day; iii) maintenance of healthy weight (18.5 kg/m2 ≤ BMI < 23 kg/m2)
- •Ability to use internet, and being accessible internet at home
- •Mobile phone user
- •Consent form to participate in the study
排除标准
- •Currently receiving any cancer treatment
- •Conditions that could limit adherence to an unsupervised exercise program such as uncontrolled congestive heart failure or angina, recent myocardial infarction, or breathing difficulties requiring oxygen use or hospitalization; walker or wheelchair use; or plans to have hip or knee replacement
- •Conditions that could interfere with a high vegetable and fruit diet, such as kidney failure or chronic warfarin use
- •Progressive malignant disease or additional primary cancers
- •Infectious condition (body temperature ≥ 37.2℃ or WBC ≥ 11,000mm3)
- •Inability to use computer or internet
- •Visual and motor dysfunction
结局指标
主要结局
Change from baseline in numbers of goal behaviors at 3 months
时间窗: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
The primary outcomes of the study are to achieve goals of healthy behaviors as followed: i) exercising≥12.5kcal/kg/week; ii) eating vegetables≥5serv/day and fruits 1-2 serv/day; iii) healthy weight (18.5kg/m2 ≤ BMI \< 25kg/m2) The primary outcome of the study is the increased number of goal behaviors.
次要结局
- Change from baseline in Stage of Change at 3 months(Baseline, 1month, 2 month, 3 month after starting the intervention)
- Change from baseline in self-efficacy at 3 months(Baseline, 1month, 2 month, 3 month after starting the intervention)
- Change from baseline in Diet quality at 3 months(Baseline, 1month, 2 month, 3 month after starting the intervention)
- Change from baseline in psychosocial outcomes at 3 months(Baseline, 1month, 2 month, 3 month after starting the intervention)
研究者
YoungSung Lee
Head
National Cancer Center, Korea