Colorectal Cancer Clinical Trial
Official title:
Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients
Verified date | May 2024 |
Source | Universidad Miguel Hernandez de Elche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Miguel Hernández | Elche | Elche/Alicante |
Spain | Hospital Universitario Puerta de Hierro | Madrid | Majadahonda/Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Miguel Hernandez de Elche | Ministerio de Ciencia e Innovación, Spain, Puerta de Hierro University Hospital |
Spain,
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. — View 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.
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. — View 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. — View 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.
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.
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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
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.
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. — View Citation
Ryan, R. M., y Deci, E. L. (2017). Self-determination theory: Basic psychological needs in motivation, development, and wellness. New York: Guilford Press.
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. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195. — View 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. — View 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.
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. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiorespiratory fitness | Rockport 1-mile walking test | Pre intervention | |
Primary | Cardiorespiratory fitness | Rockport 1-mile walking test | In the middle of the intervention (at 3 months) | |
Primary | Cardiorespiratory fitness | Rockport 1-mile walking test | At 6 months after the start of the intervention | |
Primary | Cardiorespiratory fitness | Rockport 1-mile walking test | One year after the start of the intervention | |
Primary | Strength | Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer | Pre intervention | |
Primary | 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) | |
Primary | 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 | |
Primary | 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 | Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc) | 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 | Pre intervention | |
Secondary | Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc) | 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 | In the middle of the intervention (at 3 months) | |
Secondary | Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc) | 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 | At 6 months after the start of the intervention | |
Secondary | Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc) | 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 | One year after the start of the intervention | |
Secondary | Motivation in exercise context | 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) | Pre intervention | |
Secondary | Motivation in exercise context | 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) | In the middle of the intervention (at 3 months) | |
Secondary | Motivation in exercise context | 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) | At 6 months after the start of the intervention | |
Secondary | Motivation in exercise context | 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) | One year after the start of the intervention | |
Secondary | Body composition | waist and hip circumference/ waist and hip index | Pre intervention | |
Secondary | Body composition | waist and hip circumference/ waist and hip index | In the middle of the intervention (at 3 months) | |
Secondary | Body composition | waist and hip circumference/ waist and hip index | At 6 months after the start of the intervention | |
Secondary | Body composition | waist and hip circumference/ waist and hip index | One year after the start of the intervention | |
Secondary | Autonomy support questionnaire | Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support | Pre intervention | |
Secondary | Autonomy support questionnaire | 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 | In the middle of intervention (at 3 months) | |
Secondary | Autonomy support questionnaire | 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 | At 6 months after the start of the intervention | |
Secondary | Autonomy support questionnaire | 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 | One year after the start of the intervention | |
Secondary | Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) | In general life context (from 1 to 5 points) | Pre intervention | |
Secondary | Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) | In general life context (from 1 to 5 points) | In the middle of intervention (at 3 months) | |
Secondary | Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) | In general life context (from 1 to 5 points) | At 6 months after the start of the intervention | |
Secondary | Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) | In general life context (from 1 to 5 points) | One year after the start of the intervention | |
Secondary | The scale of Basic Psychological Needs in Exercise (BPNES) will be used | In exercise context (from 1 to 5 points, being more score, more satisfaction of basic psychological needs) | Pre intervention | |
Secondary | The scale of Basic Psychological Needs in Exercise (BPNES) will be used | (from 1 to 5 points, being more score, more satisfaction of basic psychological needs) | In the middle of intervention (at 3 months) | |
Secondary | The scale of Basic Psychological Needs in Exercise (BPNES) will be used | (from 1 to 5 points, being more score, more satisfaction of basic psychological needs) | At 6 months after the start of the intervention | |
Secondary | The scale of Basic Psychological Needs in Exercise (BPNES) will be used | (from 1 to 5 points, being more score, more satisfaction of basic psychological needs) | One year after the start of the intervention | |
Secondary | Perceived barriers to physical activity participation questionnaire | 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. | Pre intervention | |
Secondary | Perceived barriers to physical activity participation questionnaire | 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. | In the middle of intervention (at 3 months) | |
Secondary | Perceived barriers to physical activity participation questionnaire | 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. | At 6 months after the start of the intervention | |
Secondary | Perceived barriers to physical activity participation questionnaire | 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. | One year after the start of the intervention | |
Secondary | Hope State Questionnaire | Scale of hope state to face the disease | Pre intervention | |
Secondary | Hope State Questionnaire | Scale of hope state to face the disease | In the middle of intervention (at 3 months) | |
Secondary | Hope State Questionnaire | Scale of hope state to face the disease | At 6 months after the start of the intervention | |
Secondary | Hope State Questionnaire | Scale of hope state to face the disease | One year after the start of the intervention | |
Secondary | Physical condition questionnaire | International Fitness Scale (IFI) | Pre intervention | |
Secondary | Physical condition questionnaire | International Fitness Scale (IFI) | In the middle of intervention (at 3 months) | |
Secondary | Physical condition questionnaire | International Fitness Scale (IFI) | At 6 months after the start of the intervention | |
Secondary | Physical condition questionnaire | International Fitness Scale (IFI) | One year after the start of the intervention | |
Secondary | Side effects of the chemotherapy | Fatigue questionnaire FACIT | Pre intervention | |
Secondary | Side effects of the chemotherapy | Fatigue questionnaire FACIT | In the middle of intervention (at 3 months) | |
Secondary | Side effects of the chemotherapy | Fatigue questionnaire FACIT | At 6 months after the start of the intervention | |
Secondary | Side effects of the chemotherapy | Fatigue questionnaire FACIT | One year after the start of the intervention | |
Secondary | Physical activity levels (subjective) | International physical activity questionnaire (IPAQ) | Pre intervention | |
Secondary | Physical activity levels (subjective) | International physical activity questionnaire (IPAQ) | In the middle of intervention (at 3 months) | |
Secondary | Physical activity levels (subjective) | International physical activity questionnaire (IPAQ) | At 6 months after the start of the intervention | |
Secondary | Physical activity levels (subjective) | International physical activity questionnaire (IPAQ) | One year after the start of the intervention | |
Secondary | Physical activity levels (objective) | Accelerometer | Pre intervention | |
Secondary | Physical activity levels (objective) | Accelerometer | In the middle of intervention (at 3 months) | |
Secondary | Physical activity levels (objective) | Accelerometer | At 6 months after the start of the intervention | |
Secondary | Physical activity levels (objective) | Accelerometer | One year after the start of the intervention | |
Secondary | Depression and anxiety | The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result) | Pre intervention | |
Secondary | Depression and anxiety | The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result) | In the middle of intervention (at 3 months) | |
Secondary | Depression and anxiety | The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result) | At 6 months after the start of the intervention | |
Secondary | Depression and anxiety | The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result) | One year after the start of the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |