Physical Activity and Motivation in Colorectal Cancer Patients

NCT04506840 | Completed

• 1 other identifier: DPS.DGC.01.19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Quality of Life; Physical Exercise; Motivation; Side Effect; Colorectal Cancer

Keywords

Chemotherapy; Exercise; Motivation; Cancer; Well-being

Outcome Measures

Primary Outcomes (8)

• Cardiorespiratory fitness

  Rockport 1-mile walking test

  Pre intervention

• Cardiorespiratory fitness

  Rockport 1-mile walking test

  In the middle of the intervention (at 3 months)

• Cardiorespiratory fitness

  Rockport 1-mile walking test

  At 6 months after the start of the intervention

• Cardiorespiratory fitness

  Rockport 1-mile walking test

  One year after the start of the intervention

• Strength

  Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

  Pre intervention

• Strength

  Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

  In the middle of the intervention (at 3 months)

• Strength

  Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

  At 6 months after the start of the intervention

• Strength

  Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

  One year after the start of the intervention

Secondary Outcomes (52)

• 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

• 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

• Motivation in exercise context

  Pre intervention

Study Arms (2)

Training group

EXPERIMENTAL

Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment

Other: Physical activity

Not training group

NO INTERVENTION

Participants will not do any intervention, they only will be perform the pre and post-tests.

Interventions

Physical activity OTHER

Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being more than 18 years
• Colorectal cancer stage II and III
• Be receiving adjuvant chemotherapy treatment after surgery
• Ecog \> 1
• No medical contraindications

You may not qualify if:

• Have a disability
• Colorectal cancer stage IV
• Presence of metastasis
• Ecog \< 1

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Puerta de Hierro University Hospital: collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (2)

Universidad Miguel Hernández

Elche, Elche/Alicante, 03202, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Majadahonda/Madrid, 28222, Spain

Location

Related Publications (23)

• 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.

  PMID: 8433390 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21239355 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15386794 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 29549149 BACKGROUND

• 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.

  PMID: 25335787 BACKGROUND

• 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.

  PMID: 13638508 BACKGROUND

• 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.

  PMID: 14399272 BACKGROUND

• 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.

  PMID: 11975886 BACKGROUND

• 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.

  PMID: 26168470 BACKGROUND

• 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.

  PMID: 17569994 BACKGROUND

• 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.

  PMID: 10022113 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24368248 BACKGROUND

• Ryan, R. M., y Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. New York: Guilford Press.

  BACKGROUND

• 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.

  PMID: 20559064 BACKGROUND

• 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.

  PMID: 20649808 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19765978 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Colorectal Neoplasms; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David González-Cutre Coll, PhD

  Miguel Hernández University of Elche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 10, 2020
• Study Start: January 21, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)