The Effects of a Nurse-led Using Wearable Technology Physical Activity Program on Health-Related Quality of Life and Physical Activity Level Among Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Self Reported Physical Activity
研究概览
简要总结
A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer. The impact of the nurse-led physical activity program on physical activity level, health-related quality of life and cognitive factors (self regulation, outcome expectation, self efficacy, perceived social support, perceived environment) will be evaluated in the study.
详细描述
This study protocol describes a randomized controlled trial with parallel group design. Participants will be Breast cancer survivors who aged 18-65, have finished active treatment (surgery, chemotherapy, and/or radiotherapy) in the previous 5 years, no evidence of recurrence and contraindications, and are completing less than 150-minutes of Moderate-Vigorous intensity Physical Activity (MVPA) per week. Participants will be randomly assigned to the intervention and control group.
Wearable Technology using Social Cognitive Theory based physical activity program (WATSOCPAP) created for the Intervention Group includes 3 different intervention components: (1) Supervised and individualized exercise plan; (2) Physical activity monitoring with activity tracker; (3) Nurse-led physical activity coaching program. Participants will be administered strengthening and aerobic exercise program, structured and individualized according to the person's individual capacity and needs, under the supervision of a physiotherapist. The activity tracker will provide real-time activity information about daily steps, time spent with MVPA (minutes/day) and sedentary time. The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory (SCT) components such as self-regulation, outcome expectation, social support and perceived environment. WATSOCPAP is a 12-week program that includes text messages, face-to-face and online interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first interview, text messages will be made according to the Social Cognitive Theory (SCT) components per weeks. Control group will receive standard care. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the intervention and control groups, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-65
- •Female gender
- •Diagnosed with stage I-III breast cancer survivors,
- •Completed active cancer primary treatment (surgery, chemotherapy, and/or radiotherapy) in the previous 5 years, excluding hormone therapy,
- •No evidence of recurrence,
- •No contraindications,
- •Less than 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity per week,
- •Having a smart mobile phone and to access and use the internet,
- •Live in Istanbul city,
- •No medical condition(s) that non-adherence to an exercise program
排除标准
- •Currently pregnant or planning to become pregnant during the study period,
- •Musculoskeletal, neurological, respiratory, metabolic or cardiovascular health problems which preclude exercise,
- •Cancer recurrence and resumption of active cancer treatment.
研究组 & 干预措施
Intervention Group
Participants will receive an exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory.
干预措施: WATSOCPAP (Behavioral)
Control Group
The control group will not take any intervention but take a standard care, the post-tests will be collected at the end of 12 weeks.
结局指标
主要结局
Self Reported Physical Activity
时间窗: Baseline, 12 weeks, 24 weeks
Change in physical activity, as measured by the "International Physical Activity Questionnaire-Short Form", from baseline to 12 and 24 weeks. Participants report frequency of light, moderate and vigorous physical activity, and average duration (minutes/week) bouts for 10 minutes or longer in the last seven days. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities. Standard MET (metabolic equivalent) values for activities were established. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as HEPA active (MET\>3000), minimally active (MET=600-3000), and inactive (MET\<600).
次要结局
- Fatigue(Baseline, 12 weeks, 24 weeks)
- BMI(Baseline, 12 weeks, 24 weeks)
- Self-efficacy For Exercise(Baseline, 12 weeks, 24 weeks)
- Outcome Expectations for Exercise(Baseline, 12 weeks, 24 weeks)
- Multidimensional Perceived Social Support Scale(Baseline, 12 weeks, 24 weeks)
- Health Related Quality of Life: EORTC-QLQ-C30(Baseline, 12 weeks, 24 weeks)
- Health Related Quality of Life-Breast Cancer Specified: EORTC-QLQ-BR23(Baseline, 12 weeks, 24 weeks)
- Self-regulation(Baseline, 12 weeks, 24 weeks)
- Perceived Environment(Baseline, 12 weeks, 24 weeks)
研究者
sura kaya
Research Assistant
Istanbul Medipol University Hospital