Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
The intervention will be a physical exercise program for colorectal cancer patients during the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the treatment and improving patients' quality of life. In addition, the investigators try to improve endurance and resistance training level, in order to achieve greater physical functionality, survival and general well-being. For this, the investigators will carry out an exercise program based mainly on muscular strength and cardiorespiratory condition. It will last 6 months, with a frequency of 3 days per week, including sessions of 60 minutes. Sessions will consist of three parts: warm-up, main part (endurance and resistance training), and cool down. An individualized and supervised progression of training will take place. The intensity levels will always be adjusted to the initial levels of the participants, always considering their preferences and comfort.
Participants' preferences and exercise history will be considered through an initial interview. Motivational strategies based on self-determination theory will be applied, since it is one of the most used theories in the field of physical exercise. This theory proposes that all people need to feel competent, autonomous and socially related. If these three needs are satisfied, participants will develop more positive (autonomous) forms of motivation, which are related to better consequences such as vitality, enjoyment, quality of life and adherence to physical activity. In addition, motivational strategies will be applied for families and healthcare professionals.
Before starting the program and at the end of it, each eligible patient will be evaluated through:
- Physical activity: strength test of lower and upper limbs, agility test, stress test for cardiorespiratory fitness, physical activity levels, physical condition and body composition.
- Psychological factors: autonomy support, basic psychological need satisfaction, motivation, quality of life, perceived barriers, depression, anxiety, hope, quality of life.
- Clinical parameters: survival rate, side effects, biological factors, treatment delays and planned treatment completion.
详细描述
Objectives and justification of the project In Spain, cancer is the second cause of death after cardiovascular diseases. However, if it is divided by sex, cancer is the leading cause of death for men and the second cause for women. In recent years there has been an increase in new cases of cancer due to population growth and aging, since 2/3 of cancer patients are older than 65 years. In addition to the impact of this disease on people's quality of life, a high economic cost has been estimated for the health system. For example, the total cost of cancer in 2015 in Spain was 7,168 million euros. This situation represents an important public health problem and therefore implies that research on the factors that can prevent or alleviate this disease should be considered as a priority.
In this regard, there is increasing scientific evidence of the physical and psychosocial benefits of exercise both during and after the treatment of this disease. Nevertheless, only 30-40% of cancer survivors perform the necessary physical activity (PA) recommended by the main medical institutions. In fact, a significant number of patients are obese (33%) and have a low cardiorespiratory condition (45%). Despite this, PA continues to decrease after diagnosis and only 5-10% of patients are physically active during treatment and 20-30% after treatment. Therefore, the development of intervention programs aimed at promoting PA should be a fundamental objective in the fight against cancer and its physical and psychosocial consequences. In this line, our general objective will be to develop a motivation PA program for colorectal cancer patients. Specifically, and considering the gaps existing in the current literature, our general objective is subdivided into the following specific objectives:
- To evaluate the physical, psychosocial and behavioural effects, in the short and medium term, of a physical exercise program in which motivational strategies based on self-determination theory are applied.
- To explore qualitatively the benefits of the physical exercise program, as well as the troubles encountered in its implementation.
- To develop an educational guide and an intervention protocol to encourage motivation and adherence to PA of colorectal cancer patients.
Methodology This study will require a sample size of 34 patients. This calculation was made through the G*power software, by means of an analysis of variance (ANOVA), adjusting the values to p <.05, with a statistical power of 80% and an effect size of 0.5. The patients will be recently diagnosed with colorectal cancer in phases II-III by the oncology service of the Hospital Universitario Puerta de Hierro de Majadahonda. Inclusion criteria include to be between 18 and 75 years old, to be undergoing chemotherapy treatment, and to not have any type of associated pathology that prevents them from performing PA. A intervention with an experimental group and a control group will be conducted, where 17 patients will be assigned to a control group, and 17 patients will perform a supervised motivational exercise program.
Measures Cardiorespiratory fitness. Stress tests adapted to the characteristics of the patients will be performed, both in the type of ergometer and in the protocol. We will use electrocardiographic recording and gas exchange analysis. Aerobic and anaerobic exercise thresholds will be established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being more than 18 years
- •Colorectal cancer stage II and III
- •Be receiving adjuvant chemotherapy treatment after surgery
- •Ecog > 1
- •No medical contraindications
排除标准
- •Have a disability
- •Colorectal cancer stage IV
- •Presence of metastasis
- •Ecog < 1
研究组 & 干预措施
Training group
Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment
干预措施: Physical activity (Other)
Not training group
Participants will not do any intervention, they only will be perform the pre and post-tests.
结局指标
主要结局
Cardiorespiratory fitness
时间窗: One year after the start of the intervention
Rockport 1-mile walking test
Strength
时间窗: One year after the start of the intervention
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Cardiorespiratory fitness
时间窗: Pre intervention
Rockport 1-mile walking test
Cardiorespiratory fitness
时间窗: In the middle of the intervention (at 3 months)
Rockport 1-mile walking test
Cardiorespiratory fitness
时间窗: At 6 months after the start of the intervention
Rockport 1-mile walking test
Strength
时间窗: Pre intervention
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Strength
时间窗: In the middle of the intervention (at 3 months)
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Strength
时间窗: At 6 months after the start of the intervention
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
次要结局
- Hope State Questionnaire(One year after the start of the intervention)
- Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)(One year after the start of the intervention)
- Body composition(One year after the start of the intervention)
- Motivation in exercise context(One year after the start of the intervention)
- Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)(One year after the start of the intervention)
- Autonomy support questionnaire(One year after the start of the intervention)
- The scale of Basic Psychological Needs in Exercise (BPNES) will be used(One year after the start of the intervention)
- Perceived barriers to physical activity participation questionnaire(One year after the start of the intervention)
- Physical condition questionnaire(One year after the start of the intervention)
- Side effects of the chemotherapy(One year after the start of the intervention)
- Physical activity levels (subjective)(One year after the start of the intervention)
- Physical activity levels (objective)(One year after the start of the intervention)
- Depression and anxiety(One year after the start of the intervention)
- Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)(Pre intervention)
- Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)(In the middle of the intervention (at 3 months))
- Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)(At 6 months after the start of the intervention)
- Motivation in exercise context(Pre intervention)
- Motivation in exercise context(In the middle of the intervention (at 3 months))
- Motivation in exercise context(At 6 months after the start of the intervention)
- Body composition(Pre intervention)
- Body composition(In the middle of the intervention (at 3 months))
- Body composition(At 6 months after the start of the intervention)
- Autonomy support questionnaire(Pre intervention)
- Autonomy support questionnaire(In the middle of intervention (at 3 months))
- Autonomy support questionnaire(At 6 months after the start of the intervention)
- Physical activity levels (objective)(In the middle of intervention (at 3 months))
- Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)(Pre intervention)
- Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)(In the middle of intervention (at 3 months))
- Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)(At 6 months after the start of the intervention)
- The scale of Basic Psychological Needs in Exercise (BPNES) will be used(Pre intervention)
- The scale of Basic Psychological Needs in Exercise (BPNES) will be used(In the middle of intervention (at 3 months))
- The scale of Basic Psychological Needs in Exercise (BPNES) will be used(At 6 months after the start of the intervention)
- Perceived barriers to physical activity participation questionnaire(Pre intervention)
- Perceived barriers to physical activity participation questionnaire(In the middle of intervention (at 3 months))
- Perceived barriers to physical activity participation questionnaire(At 6 months after the start of the intervention)
- Hope State Questionnaire(Pre intervention)
- Hope State Questionnaire(In the middle of intervention (at 3 months))
- Hope State Questionnaire(At 6 months after the start of the intervention)
- Physical condition questionnaire(Pre intervention)
- Physical condition questionnaire(In the middle of intervention (at 3 months))
- Physical condition questionnaire(At 6 months after the start of the intervention)
- Side effects of the chemotherapy(Pre intervention)
- Side effects of the chemotherapy(In the middle of intervention (at 3 months))
- Side effects of the chemotherapy(At 6 months after the start of the intervention)
- Physical activity levels (subjective)(Pre intervention)
- Physical activity levels (subjective)(In the middle of intervention (at 3 months))
- Physical activity levels (subjective)(At 6 months after the start of the intervention)
- Physical activity levels (objective)(Pre intervention)
- Physical activity levels (objective)(At 6 months after the start of the intervention)
- Depression and anxiety(Pre intervention)
- Depression and anxiety(In the middle of intervention (at 3 months))
- Depression and anxiety(At 6 months after the start of the intervention)
研究者
David González-Cutre Coll
Senior Lecturer
Universidad Miguel Hernandez de Elche