NCT04506840 — Physical Activity and Motivation in Colorectal Cancer Patients · CancerIndex
Clinical trial · Interventional
Physical Activity and Motivation in Colorectal Cancer Patients
Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment
interventionNames
Other: Physical activity
type
NO_INTERVENTION
label
Not training group
description
Participants will not do any intervention, they only will be perform the pre and post-tests.
Primary outcomes (8)
measure
Cardiorespiratory fitness
timeFrame
Pre intervention
description
Rockport 1-mile walking test
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion criteria:
* Being more than 18 years
* Colorectal cancer stage II and III
* Be receiving adjuvant chemotherapy treatment after surgery
* Ecog \> 1
* No medical contraindications
Exclusion criteria:
* Have a disability
* Colorectal cancer stage IV
* Presence of metastasis
* Ecog \< 1
References
Publications (23)
BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
BACKGROUNDAlvero Cruz, J. R., Armesilla, M. D. C., Herrero-de-Lucas, A., Riaza, L. M., Pascual, C. M., Manzañido, J. P., … Belando, J. E. S. (2010). Body composition assessment in sports medicine. Statement of Spanish group of kinanthropometry of Spanish federation of sports medicine. Version 2010. Archivos de Medicina del Deporte, 27, 330-344.
BACKGROUNDArraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y. PMID 21239355
BACKGROUNDCourneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999b). Understanding exercise motivation in colorectal cancer patients: A prospective study using the theory of planned behavior. Rehabilitation Psychology, 44, 68-84.
BACKGROUNDCourneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999a). Physical exercise and quality of life in postsurgical colorectal cancer patients. Psychology, Health, & Medicine, 4, 181-187.
BACKGROUNDCourneya KS, Friedenreich CM, Quinney HA, Fields AL, Jones LW, Fairey AS. Predictors of adherence and contamination in a randomized trial of exercise in colorectal cancer survivors. Psychooncology. 2004 Dec;13(12):857-66. doi: 10.1002/pon.802. PMID 15386794
BACKGROUNDCraig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
measure
Cardiorespiratory fitness
timeFrame
In the middle of the intervention (at 3 months)
description
Rockport 1-mile walking test
measure
Cardiorespiratory fitness
timeFrame
At 6 months after the start of the intervention
description
Rockport 1-mile walking test
measure
Cardiorespiratory fitness
timeFrame
One year after the start of the intervention
description
Rockport 1-mile walking test
measure
Strength
timeFrame
Pre intervention
description
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure
Strength
timeFrame
In the middle of the intervention (at 3 months)
description
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure
Strength
timeFrame
At 6 months after the start of the intervention
description
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
measure
Strength
timeFrame
One year after the start of the intervention
description
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Secondary outcomes (52)
measure
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
timeFrame
Pre intervention
description
Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
timeFrame
In the middle of the intervention (at 3 months)
description
Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
timeFrame
At 6 months after the start of the intervention
description
Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
timeFrame
One year after the start of the intervention
description
Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales
measure
Motivation in exercise context
timeFrame
Pre intervention
description
Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure
Motivation in exercise context
timeFrame
In the middle of the intervention (at 3 months)
description
Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure
Motivation in exercise context
timeFrame
At 6 months after the start of the intervention
description
Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure
Motivation in exercise context
timeFrame
One year after the start of the intervention
description
Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)
measure
Body composition
timeFrame
Pre intervention
description
waist and hip circumference/ waist and hip index
measure
Body composition
timeFrame
In the middle of the intervention (at 3 months)
description
waist and hip circumference/ waist and hip index
measure
Body composition
timeFrame
At 6 months after the start of the intervention
description
waist and hip circumference/ waist and hip index
measure
Body composition
timeFrame
One year after the start of the intervention
description
waist and hip circumference/ waist and hip index
measure
Autonomy support questionnaire
timeFrame
Pre intervention
description
Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure
Autonomy support questionnaire
timeFrame
In the middle of intervention (at 3 months)
description
Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure
Autonomy support questionnaire
timeFrame
At 6 months after the start of the intervention
description
Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure
Autonomy support questionnaire
timeFrame
One year after the start of the intervention
description
Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
measure
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame
Pre intervention
description
In general life context (from 1 to 5 points)
measure
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame
In the middle of intervention (at 3 months)
description
In general life context (from 1 to 5 points)
measure
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame
At 6 months after the start of the intervention
description
In general life context (from 1 to 5 points)
measure
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame
One year after the start of the intervention
description
In general life context (from 1 to 5 points)
measure
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame
Pre intervention
description
In exercise context (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame
In the middle of intervention (at 3 months)
description
(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame
At 6 months after the start of the intervention
description
(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame
One year after the start of the intervention
description
(from 1 to 5 points, being more score, more satisfaction of basic psychological needs)
measure
Perceived barriers to physical activity participation questionnaire
timeFrame
Pre intervention
description
On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure
Perceived barriers to physical activity participation questionnaire
timeFrame
In the middle of intervention (at 3 months)
description
On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure
Perceived barriers to physical activity participation questionnaire
timeFrame
At 6 months after the start of the intervention
description
On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure
Perceived barriers to physical activity participation questionnaire
timeFrame
One year after the start of the intervention
description
On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.
measure
Hope State Questionnaire
timeFrame
Pre intervention
description
Scale of hope state to face the disease
measure
Hope State Questionnaire
timeFrame
In the middle of intervention (at 3 months)
description
Scale of hope state to face the disease
measure
Hope State Questionnaire
timeFrame
At 6 months after the start of the intervention
description
Scale of hope state to face the disease
measure
Hope State Questionnaire
timeFrame
One year after the start of the intervention
description
Scale of hope state to face the disease
measure
Physical condition questionnaire
timeFrame
Pre intervention
description
International Fitness Scale (IFI)
measure
Physical condition questionnaire
timeFrame
In the middle of intervention (at 3 months)
description
International Fitness Scale (IFI)
measure
Physical condition questionnaire
timeFrame
At 6 months after the start of the intervention
description
International Fitness Scale (IFI)
measure
Physical condition questionnaire
timeFrame
One year after the start of the intervention
description
International Fitness Scale (IFI)
measure
Side effects of the chemotherapy
timeFrame
Pre intervention
description
Fatigue questionnaire FACIT
measure
Side effects of the chemotherapy
timeFrame
In the middle of intervention (at 3 months)
description
Fatigue questionnaire FACIT
measure
Side effects of the chemotherapy
timeFrame
At 6 months after the start of the intervention
description
Fatigue questionnaire FACIT
measure
Side effects of the chemotherapy
timeFrame
One year after the start of the intervention
description
Fatigue questionnaire FACIT
measure
Physical activity levels (subjective)
timeFrame
Pre intervention
description
International physical activity questionnaire (IPAQ)
measure
Physical activity levels (subjective)
timeFrame
In the middle of intervention (at 3 months)
description
International physical activity questionnaire (IPAQ)
measure
Physical activity levels (subjective)
timeFrame
At 6 months after the start of the intervention
description
International physical activity questionnaire (IPAQ)
measure
Physical activity levels (subjective)
timeFrame
One year after the start of the intervention
description
International physical activity questionnaire (IPAQ)
measure
Physical activity levels (objective)
timeFrame
Pre intervention
description
Accelerometer
measure
Physical activity levels (objective)
timeFrame
In the middle of intervention (at 3 months)
description
Accelerometer
measure
Physical activity levels (objective)
timeFrame
At 6 months after the start of the intervention
description
Accelerometer
measure
Physical activity levels (objective)
timeFrame
One year after the start of the intervention
description
Accelerometer
measure
Depression and anxiety
timeFrame
Pre intervention
description
The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure
Depression and anxiety
timeFrame
In the middle of intervention (at 3 months)
description
The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure
Depression and anxiety
timeFrame
At 6 months after the start of the intervention
description
The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
measure
Depression and anxiety
timeFrame
One year after the start of the intervention
description
The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)
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