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Clinical Trials/NCT04506840
NCT04506840CompletedNot Applicable

Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients

Universidad Miguel Hernandez de Elche4 sites in 1 country32 target enrollmentStarted: January 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
4
Primary Endpoint
Cardiorespiratory fitness

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cardiorespiratory fitness

Time Frame: One year after the start of the intervention

Rockport 1-mile walking test

Strength

Time Frame: 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

Secondary Outcomes

  • 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)
  • Hope State 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David González-Cutre Coll

Senior Lecturer

Universidad Miguel Hernandez de Elche

Study Sites (4)

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