Clinical trial NCT04506840: Physical Activity and Motivation in Colorectal Cancer Patients
Official title: Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Physical Exercise
Motivation
Side Effect
Colorectal Cancer
Keywords: Chemotherapy
Exercise
Motivation
Cancer
Well-being
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Puerta de Hierro University Hospital
name: Ministerio de Ciencia e Innovación, Spain
First posted: 2020-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Quality of life. The validated Spanish version of the EORTC-QLQ-CR30 will be used for patients with colorectal cancer.

Body composition. Anthropometries will be carried out to estimate body composition parameters.

Biological parameters. The usual analytics carried out in the hospital during the treatment will be used to check the patient's health status and the side effects of the chemotherapy treatment.

Anxiety. The validated version in Spanish of the Hamilton Anxiety Scale will be used.

Depression. The Spanish version of the Hamilton Depression Scale will be used. Autonomy support. The Spanish version of the Perceived Autonomy Support for Exercise Settings will be used.

Perceived barriers to do PA. This scale will be translated and validated to the Spanish context.

Basic psychological needs in exercise. We will use the Basic Psychological Needs in Exercise Scale.

Basic psychological needs in life. The Spanish version of the Basic Psychological Need Satisfaction and Frustration Scale will be used.

Types of motivation. To measure motivation towards PA, the Behavioural Regulation in Exercise Questionnaire will be for PA levels. The Spanish version of the IPAQ questionnaire will be used. On the other hand, PA will be measured in a direct and objective way through portable GT3X accelerometers.

Design, procedure and data analysis The intervention program will be carried out at the Hospital Universitario Puerta de Hierro of Majadahonda. The program will last 6 months, with three weekly one-hour sessions, and will comply with the recommendations established by the American Cancer Society and the American College of Sports Medicine. The safety precautions and contraindications identified by these institutions for colorectal cancer patients will be especially considered. The program will include aerobic sessions at moderate and vigorous intensities, as well as strength work. Patients will be monitored to model exercise loads individually.

The measurements will be made just before starting the PA program (T1) in the case of the experimental group, at an initial time of the equivalent treatment in the case of the control group. The same measures will be carried out 6 months later (T2). For PA levels, instead of measuring them just after the end of the program, we will wait another month so that patients have been able to recover their usual PA levels after the shock that can mean for them to face the end of our program. In the control group, PA levels will also be evaluated one month after T2. To test the effects of the program, all measurements will be performed 6 months after T2 in both groups (T3).

Additionally, qualitative methodology will be used, so that the 17 patients of the experimental group will be interviewed to know the factors related to their adherence to the PA program and the benefits perceived by them with their participation. Qualitative data collection will be reinforced with field notes compiled in research diaries by observers who will be present during the development of the program. Relatives and health professionals will also be interviewed to learn their perspective regarding the benefits of the program and adherence to it in these patients.

In order to promote adherence to the program and to educate in autonomous PA habits when it ends, motivational strategies based on the self-determination theory will be used. Specific strategies will be developed for this group, based on previous works and educational guides for colorectal cancer patients. The instructor in charge of directing the program will be trained in several sessions to use motivational strategies based on this theory. Once the program is finished, an educational guide of motivational strategies for the promotion of PA in patients with colorectal cancer will be developed and published from the perspective of self-determination theory.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Pre intervention
measure: Cardiorespiratory fitness
timeFrame: In the middle of the intervention (at 3 months)
measure: Cardiorespiratory fitness
timeFrame: At 6 months after the start of the intervention
measure: Cardiorespiratory fitness
timeFrame: One year after the start of the intervention
measure: Strength
timeFrame: Pre intervention
measure: Strength
timeFrame: In the middle of the intervention (at 3 months)
measure: Strength
timeFrame: At 6 months after the start of the intervention
measure: Strength
timeFrame: One year after the start of the intervention
Secondary outcomes:
measure: Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
timeFrame: Pre intervention
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)
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
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
measure: Motivation in exercise context
timeFrame: Pre intervention
measure: Motivation in exercise context
timeFrame: In the middle of the intervention (at 3 months)
measure: Motivation in exercise context
timeFrame: At 6 months after the start of the intervention
measure: Motivation in exercise context
timeFrame: One year after the start of the intervention
measure: Body composition
timeFrame: Pre intervention
measure: Body composition
timeFrame: In the middle of the intervention (at 3 months)
measure: Body composition
timeFrame: At 6 months after the start of the intervention
measure: Body composition
timeFrame: One year after the start of the intervention
measure: Autonomy support questionnaire
timeFrame: Pre intervention
measure: Autonomy support questionnaire
timeFrame: In the middle of intervention (at 3 months)
measure: Autonomy support questionnaire
timeFrame: At 6 months after the start of the intervention
measure: Autonomy support questionnaire
timeFrame: One year after the start of the intervention
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame: Pre intervention
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame: In the middle of intervention (at 3 months)
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame: At 6 months after the start of the intervention
measure: Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
timeFrame: One year after the start of the intervention
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame: Pre intervention
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame: In the middle of intervention (at 3 months)
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame: At 6 months after the start of the intervention
measure: The scale of Basic Psychological Needs in Exercise (BPNES) will be used
timeFrame: One year after the start of the intervention
measure: Perceived barriers to physical activity participation questionnaire
timeFrame: Pre intervention
measure: Perceived barriers to physical activity participation questionnaire
timeFrame: In the middle of intervention (at 3 months)
measure: Perceived barriers to physical activity participation questionnaire
timeFrame: At 6 months after the start of the intervention
measure: Perceived barriers to physical activity participation questionnaire
timeFrame: One year after the start of the intervention
measure: Hope State Questionnaire
timeFrame: Pre intervention
measure: Hope State Questionnaire
timeFrame: In the middle of intervention (at 3 months)
measure: Hope State Questionnaire
timeFrame: At 6 months after the start of the intervention
measure: Hope State Questionnaire
timeFrame: One year after the start of the intervention
measure: Physical condition questionnaire
timeFrame: Pre intervention
measure: Physical condition questionnaire
timeFrame: In the middle of intervention (at 3 months)
measure: Physical condition questionnaire
timeFrame: At 6 months after the start of the intervention
measure: Physical condition questionnaire
timeFrame: One year after the start of the intervention
measure: Side effects of the chemotherapy
timeFrame: Pre intervention
measure: Side effects of the chemotherapy
timeFrame: In the middle of intervention (at 3 months)
measure: Side effects of the chemotherapy
timeFrame: At 6 months after the start of the intervention
measure: Side effects of the chemotherapy
timeFrame: One year after the start of the intervention
measure: Physical activity levels (subjective)
timeFrame: Pre intervention
measure: Physical activity levels (subjective)
timeFrame: In the middle of intervention (at 3 months)
measure: Physical activity levels (subjective)
timeFrame: At 6 months after the start of the intervention
measure: Physical activity levels (subjective)
timeFrame: One year after the start of the intervention
measure: Physical activity levels (objective)
timeFrame: Pre intervention
measure: Physical activity levels (objective)
timeFrame: In the middle of intervention (at 3 months)
measure: Physical activity levels (objective)
timeFrame: At 6 months after the start of the intervention
measure: Physical activity levels (objective)
timeFrame: One year after the start of the intervention
measure: Depression and anxiety
timeFrame: Pre intervention
measure: Depression and anxiety
timeFrame: In the middle of intervention (at 3 months)
measure: Depression and anxiety
timeFrame: At 6 months after the start of the intervention
measure: Depression and anxiety
timeFrame: One year after the start of the intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernández
state: Elche/Alicante
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Majadahonda/Madrid
Study officials:
affiliation: Miguel Hernández University of Elche
name: David González-Cutre Coll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aaronson 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.
citation: Alvero 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.
citation: Arraras 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.
citation: Courneya, 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.
citation: Courneya, 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.
citation: Courneya 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.
citation: Craig 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.
citation: Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct;52(20):1311. doi: 10.1136/bjsports-2017-098285. Epub 2018 Mar 16.
citation: Garcia DO, Thomson CA. Physical activity and cancer survivorship. Nutr Clin Pract. 2014 Dec;29(6):768-79. doi: 10.1177/0884533614551969. Epub 2014 Oct 21.
citation: HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
citation: HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
citation: Lobo A, Chamorro L, Luque A, Dal-Re R, Badia X, Baro E; Grupo de Validacion en Espanol de Escalas Psicometricas (GVEEP). [Validation of the Spanish versions of the Montgomery-Asberg depression and Hamilton anxiety rating scales]. Med Clin (Barc). 2002 Apr 13;118(13):493-9. doi: 10.1016/s0025-7753(02)72429-9. Spanish.
citation: Ng JY, Ntoumanis N, Thogersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, Williams GC. Self-Determination Theory Applied to Health Contexts: A Meta-Analysis. Perspect Psychol Sci. 2012 Jul;7(4):325-40. doi: 10.1177/1745691612447309.
citation: Peddle CJ, Plotnikoff RC, Wild TC, Au HJ, Courneya KS. Medical, demographic, and psychosocial correlates of exercise in colorectal cancer survivors: an application of self-determination theory. Support Care Cancer. 2008 Jan;16(1):9-17. doi: 10.1007/s00520-007-0272-5. Epub 2007 Jun 15.
citation: Rantanen T, Guralnik JM, Foley D, Masaki K, Leveille S, Curb JD, White L. Midlife hand grip strength as a predictor of old age disability. JAMA. 1999 Feb 10;281(6):558-60. doi: 10.1001/jama.281.6.558.
citation: Roman, B., Serra-Majem, L., Hagstromer, M., Ramon, J., Ribas, L., y Sjostrom, M. (2006). International Physical Activity Questionnaire: Reliability and validity in Spain. Medicine and Science in Sports and Exercise, 38, S563. doi:10.1249/00005768-200605001-03214
citation: Romero-Elías, M., González-Cutre, D., Beltrán-Carrillo, V. J., y Cervelló, E. (2017). Factors that promote or hinder physical activity participation in patients with colorectal cancer: A systematic review. Psychology, Society, & Education, 9, 201-226.
citation: Ruiz-Casado A, Verdugo AS, Solano MJ, Aldazabal IP, Fiuza-Luces C, Alejo LB, del Hierro JR, Palomo I, Aguado-Arroyo O, Garatachea N, Cebolla H, Lucia A. Objectively assessed physical activity levels in Spanish cancer survivors. Oncol Nurs Forum. 2014 Jan 1;41(1):E12-20. doi: 10.1188/14.ONF.E12-E20.
citation: Ryan, R. M., y Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. New York: Guilford Press.
citation: Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
citation: Spence RR, Heesch KC, Brown WJ. Colorectal cancer survivors' exercise experiences and preferences: qualitative findings from an exercise rehabilitation programme immediately after chemotherapy. Eur J Cancer Care (Engl). 2011 Mar;20(2):257-66. doi: 10.1111/j.1365-2354.2010.01214.x.
citation: Vlachopoulos, S. P., y Michailidou, S. (2006). Development and initial validation of a measure of autonomy, competence, and relatedness in exercise: The Basic Psychological Needs in Exercise Scale. Measurement in Physical Education and Exercise Science, 10, 179-201.
citation: Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson CD, Pilkington SA, Arraras J, Ben-Josef E, Pullyblank AM, Fayers P, Blazeby JM; European Organisation for the Research and Treatment of Cancer Quality of Life Group. Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer. 2009 Nov;45(17):3017-26. doi: 10.1016/j.ejca.2009.08.014. Epub 2009 Sep 16.