Quality of LifeNCT04506840
Physical Activity and Motivation in Colorectal Cancer Patients
A study testing Physical activity in people with Quality of Life and Physical Exercise, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Physical Exercise, Motivation
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Jan 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being more than 18 years
- Colorectal cancer stage II and III
- Be receiving adjuvant chemotherapy treatment after surgery
- Ecog > 1
- No medical contraindications
Who cannot join
- Have a disability
- Colorectal cancer stage IV
- Presence of metastasis
- Ecog < 1
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Miguel Hernández
Elche, Elche/Alicante, 03202
Hospital Universitario Puerta de Hierro
Madrid, Majadahonda/Madrid, 28222
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Quality of Life, Physical Exercise, Motivation, Side Effect, Colorectal Cancer
- Being tested
- Physical activity
- Keywords
- Chemotherapy, Exercise, Motivation, Cancer, Well-being
- Medical subject headings
- Motor Activity, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Participants will participate in a program of physical exercise during the adjuvant chemotherapy treatment Receives: Other: Physical activity |
| Not training group | No intervention | Participants will not do any intervention, they only will be perform the pre and post-tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Rockport 1-mile walking test
Measured: Pre intervention
Cardiorespiratory fitness
Rockport 1-mile walking test
Measured: In the middle of the intervention (at 3 months)
Cardiorespiratory fitness
Rockport 1-mile walking test
Measured: At 6 months after the start of the intervention
Cardiorespiratory fitness
Rockport 1-mile walking test
Measured: 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
Measured: Pre intervention
Strength
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Measured: 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
Measured: 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
Measured: 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)
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
Measured: Pre intervention
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
Measured: 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)
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
Measured: 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)
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
Measured: One year after the start of the intervention
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)
Measured: Pre intervention
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)
Measured: In the middle of the intervention (at 3 months)
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)
Measured: At 6 months after the start of the intervention
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)
Measured: One year after the start of the intervention
Body composition
waist and hip circumference/ waist and hip index
Measured: Pre intervention
Body composition
waist and hip circumference/ waist and hip index
Measured: In the middle of the intervention (at 3 months)
Body composition
waist and hip circumference/ waist and hip index
Measured: At 6 months after the start of the intervention
Body composition
waist and hip circumference/ waist and hip index
Measured: One year after the start of the intervention
Autonomy support questionnaire
Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support
Measured: Pre intervention
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
Measured: In the middle of intervention (at 3 months)
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
Measured: At 6 months after the start of the intervention
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
Measured: One year after the start of the intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
In general life context (from 1 to 5 points)
Measured: Pre intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
In general life context (from 1 to 5 points)
Measured: In the middle of intervention (at 3 months)
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
In general life context (from 1 to 5 points)
Measured: At 6 months after the start of the intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
In general life context (from 1 to 5 points)
Measured: One year after the start of the intervention
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)
Measured: Pre intervention
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)
Measured: In the middle of intervention (at 3 months)
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)
Measured: At 6 months after the start of the intervention
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)
Measured: One year after the start of the intervention
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.
Measured: Pre intervention
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.
Measured: In the middle of intervention (at 3 months)
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.
Measured: At 6 months after the start of the intervention
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.
Measured: One year after the start of the intervention
Hope State Questionnaire
Scale of hope state to face the disease
Measured: Pre intervention
Hope State Questionnaire
Scale of hope state to face the disease
Measured: In the middle of intervention (at 3 months)
Hope State Questionnaire
Scale of hope state to face the disease
Measured: At 6 months after the start of the intervention
Hope State Questionnaire
Scale of hope state to face the disease
Measured: One year after the start of the intervention
Physical condition questionnaire
International Fitness Scale (IFI)
Measured: Pre intervention
Physical condition questionnaire
International Fitness Scale (IFI)
Measured: In the middle of intervention (at 3 months)
Physical condition questionnaire
International Fitness Scale (IFI)
Measured: At 6 months after the start of the intervention
Physical condition questionnaire
International Fitness Scale (IFI)
Measured: One year after the start of the intervention
Side effects of the chemotherapy
Fatigue questionnaire FACIT
Measured: Pre intervention
Side effects of the chemotherapy
Fatigue questionnaire FACIT
Measured: In the middle of intervention (at 3 months)
Side effects of the chemotherapy
Fatigue questionnaire FACIT
Measured: At 6 months after the start of the intervention
Side effects of the chemotherapy
Fatigue questionnaire FACIT
Measured: One year after the start of the intervention
Physical activity levels (subjective)
International physical activity questionnaire (IPAQ)
Measured: Pre intervention
Physical activity levels (subjective)
International physical activity questionnaire (IPAQ)
Measured: In the middle of intervention (at 3 months)
Physical activity levels (subjective)
International physical activity questionnaire (IPAQ)
Measured: At 6 months after the start of the intervention
Physical activity levels (subjective)
International physical activity questionnaire (IPAQ)
Measured: One year after the start of the intervention
Physical activity levels (objective)
Accelerometer
Measured: Pre intervention
Physical activity levels (objective)
Accelerometer
Measured: In the middle of intervention (at 3 months)
Physical activity levels (objective)
Accelerometer
Measured: At 6 months after the start of the intervention
Physical activity levels (objective)
Accelerometer
Measured: One year after the start of the intervention
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)
Measured: Pre intervention
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)
Measured: In the middle of intervention (at 3 months)
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)
Measured: At 6 months after the start of the intervention
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)
Measured: One year after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start21 Jan 2020
- Primary completion30 Jun 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Puerta de Hierro University Hospital, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, David González-Cutre Coll, Universidad Miguel Hernandez de Elche
- Investigators
- David González-Cutre Coll, PhD, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506840
- Sponsor's protocol ID
- DPS.DGC.01.19
- Status last verified
- May 2024
- First submitted
- 21 Jul 2020
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8433390Alvero 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.
PubMed 21239355Courneya, 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.
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 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.
PubMed 15386794Craig 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.
PubMed 12900694Fuller 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.
PubMed 29549149Garcia 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.
PubMed 25335787HAMILTON 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.
PubMed 13638508HAMILTON 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.
PubMed 14399272Lobo 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.
PubMed 11975886Ng 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.
PubMed 26168470Peddle 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.
PubMed 17569994Rantanen 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.
PubMed 10022113
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04506840
- Acronym / sponsor ID
- DPS.DGC.01.19
- Conditions
- Quality of Life, Physical Exercise, Motivation, Side Effect, Colorectal Cancer
- Keywords
- Chemotherapy, Exercise, Motivation, Cancer, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Puerta de Hierro University Hospital, Ministerio de Ciencia e Innovación, Spain
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Physical activityParticipants will participate in a program of physical exercise during the adjuvant chemotherapy treatment |
| Not training group | No intervention | –Participants will not do any intervention, they only will be perform the pre and post-tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being more than 18 years
- Colorectal cancer stage II and III
- Be receiving adjuvant chemotherapy treatment after surgery
- Ecog > 1
- No medical contraindications
Key exclusion criteria (4 listed)
- Have a disability
- Colorectal cancer stage IV
- Presence of metastasis
- Ecog < 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPatients 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 | Other | Training group |
Primary outcome
Cardiorespiratory fitness
Time frame: Pre intervention
Rockport 1-mile walking test
Cardiorespiratory fitness
Time frame: In the middle of the intervention (at 3 months)
Rockport 1-mile walking test
Cardiorespiratory fitness
Time frame: At 6 months after the start of the intervention
Rockport 1-mile walking test
Cardiorespiratory fitness
Time frame: One year after the start of the intervention
Rockport 1-mile walking test
Strength
Time frame: Pre intervention
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Strength
Time frame: In the middle of the intervention (at 3 months)
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
Strength
Time frame: At 6 months after the start of the intervention
Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer
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
52 secondary outcomes
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
Time frame: Pre intervention
Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)
Time frame: 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)
Time frame: 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)
Time frame: One year after the start of the intervention
Motivation in exercise context
Time frame: Pre intervention
Motivation in exercise context
Time frame: In the middle of the intervention (at 3 months)
Motivation in exercise context
Time frame: At 6 months after the start of the intervention
Motivation in exercise context
Time frame: One year after the start of the intervention
Body composition
Time frame: Pre intervention
Body composition
Time frame: In the middle of the intervention (at 3 months)
Body composition
Time frame: At 6 months after the start of the intervention
Body composition
Time frame: One year after the start of the intervention
Autonomy support questionnaire
Time frame: Pre intervention
Autonomy support questionnaire
Time frame: In the middle of intervention (at 3 months)
Autonomy support questionnaire
Time frame: At 6 months after the start of the intervention
Autonomy support questionnaire
Time frame: One year after the start of the intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Time frame: Pre intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Time frame: In the middle of intervention (at 3 months)
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Time frame: At 6 months after the start of the intervention
Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
Time frame: One year after the start of the intervention
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
Time frame: Pre intervention
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
Time frame: In the middle of intervention (at 3 months)
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
Time frame: At 6 months after the start of the intervention
The scale of Basic Psychological Needs in Exercise (BPNES) will be used
Time frame: One year after the start of the intervention
Perceived barriers to physical activity participation questionnaire
Time frame: Pre intervention
Perceived barriers to physical activity participation questionnaire
Time frame: In the middle of intervention (at 3 months)
Perceived barriers to physical activity participation questionnaire
Time frame: At 6 months after the start of the intervention
Perceived barriers to physical activity participation questionnaire
Time frame: One year after the start of the intervention
Hope State Questionnaire
Time frame: Pre intervention
Hope State Questionnaire
Time frame: In the middle of intervention (at 3 months)
Hope State Questionnaire
Time frame: At 6 months after the start of the intervention
Hope State Questionnaire
Time frame: One year after the start of the intervention
Physical condition questionnaire
Time frame: Pre intervention
Physical condition questionnaire
Time frame: In the middle of intervention (at 3 months)
Physical condition questionnaire
Time frame: At 6 months after the start of the intervention
Physical condition questionnaire
Time frame: One year after the start of the intervention
Side effects of the chemotherapy
Time frame: Pre intervention
Side effects of the chemotherapy
Time frame: In the middle of intervention (at 3 months)
Side effects of the chemotherapy
Time frame: At 6 months after the start of the intervention
Side effects of the chemotherapy
Time frame: One year after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 8433390Aaronson 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.
- 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.
- Background: PubMed 21239355Arraras 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.
- 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.
- Background: PubMed 15386794Courneya 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 29549149Fuller 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.
- Background: PubMed 25335787Garcia 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.
- Background: PubMed 13638508HAMILTON 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.
- Background: PubMed 14399272HAMILTON 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.
- Background: PubMed 11975886Lobo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David González-Cutre Coll, PhD principal investigator
Universidad Miguel Hernandez de Elche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Quality of Life and Physical Exercise, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: Pre intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506840, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.