Endometrial CancerNCT00501761
Physical Activity After Endometrial Cancer
An observational study of Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Researchers propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical activity intervention. The specific aims of the study are: 1. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Personalized Exercise Program, Questionnaire and Suggested Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 2025
- Phase
- Observational
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants that have survived endometrial cancer and healthy participants that have no history of invasive cancer.
Who may be able to join
- Survivor of endometrial cancer (survivor group only).
- Was diagnosed with Stage I, II, or IIIa endometrial cancer in the past five years (survivor group only).
- Completed surgical or radiation treatment at least 6 months ago (survivor group only).
- No history of invasive cancer, except for non-melanoma skin cancer (no cancer history group).
- Age 45 years of older (no cancer history group).
- Female (no cancer history group).
Show all 12Show fewer
- Not pregnant by self-report (no cancer history group).
- Speaks and reads English (all participants).
- Oriented to person, place, and time (all participants).
- Has clearance from their physician to engage in moderate physical activity (all participants).
- For web-based maintenance intervention pilot study, women will be included if they have completed their third follow-up assessment.
- For web-based maintenance intervention, women are considered ineligible if they do not have internet access.
Who cannot join
- Engages in programmatic physical activity at moderate or greater intensity on five or more days per week for 30 minutes or more, or vigorous intensity activity 20 minutes or more at least 3 days per week, and have maintained this level of activity for six months or longer.
- Have any condition defined by the American College of Sports Medicine's as "absolute contraindications to exercise testing" (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
- Have any condition as defined by the American College of Sports Medicine's as "relative contraindications to exercise testing" (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
- Right or left bundle branch block.
- Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
- Uncontrolled asthma
- Have other medical contraindications as defined by the patient's physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Social Cognitive Theory and Physical Activity After Endometrial Cancer
Researchers propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical activity intervention.
The specific aims of the study are:
- To test a Social Cognitive Theory-based model of physical activity adoption among sedentary endometrial cancer survivors receiving an intervention to increase physical activity. The model includes hypotheses about the effect of self-efficacy and outcome expectations on physical activity adherence, the effects of four sources of efficacy information (mastery experience, verbal persuasion, modeling, and physiological feedback) on self-efficacy and subsequent exercise adherence, and the influence of physical activity outcomes on subsequent self-efficacy, outcome expectations, and physical activity.
- To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
- To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
- To test the effects of adherence to physical activity on endometrial cancer survivors' quality of life and stress as assessed by self-report and salivary cortisol.
- To test the feasibility of a web-based maintenance intervention for women who have completed the phone counseling portion of the study.
Read the detailed description
Women who have been successfully treated for endometrial cancer will be invited to participate in the study. After you agree to participate you will be asked questions about your physical activity to make sure you are eligible. You will only be allowed to participate in this study if your physician feels it is safe for you to engage in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about you cancer and treatment history will be collected from your medical records as part of the study.
If you agree to take part in this study, you will come to M. D. Anderson for study visits twice at the beginning of the study. If needed, the activities for these first 2 visits can be combined into 1 visit, though it will mean that the single visit will take a little longer than each of the 2 visits. After the first visit, you will be asked to return after 2, 4, and 6 months. Each visit will take about 2 hours. Three (3) months and 6 months after the last visit, you will be called to answer questions about your physical activity. It will take about 10 minutes to answer the questions. In case you cannot be reached by phone, the questionnaires will be mailed to you. You will be asked to mail the questionnaire back in with a pre-paid addressed envelope.
At the first visit you will complete questionnaires about your quality of life, medical conditions, and how physically active you are currently and have been in the past. The questionnaires will take about 45 minutes to complete. A baseline electrocardiogram (ECG-a test to measure the electrical activity of the heart) will be performed. If your ECG test is not normal you will be informed. You will practice using the exercise bicycle that will be used in the fitness testing at the later visits. You will be asked to provide a saliva sample by placing a cotton roll in your mouth until it is saturated and then placing it back in a plastic vial without using your hands. This sample will be for practice and will be discarded.
You will also be given an ActiGraph to wear for 5 days. This is a small light device that you wear on your waist during the day. It records how active you are. You will also be given a handheld computer that you will use for 5 days to answer questions about physical activity. The computers are small (about 4-1/2 by 3 inches) and light (about 4 1/2 ounces). The computer will prompt you to enter information up to 8 times a day. Answering these questions will take up to 5 minutes. You will be asked to return the Actigraph and the computer on your second visit.
After 5 days, you will come back to M. D. Anderson for your second study visit. During this visit, you will be asked to complete questionnaires about physical activity that will take about 1 hour. You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart) performed. You will perform a fitness test, in which you will ride a stationary bicycle while your heart rate, blood pressure, and respiration (breathing) are monitored. You will also be asked to complete two tasks on a computer. After the second visit, you will again use the handheld computer and wear an Actigraph for 5 days. You will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days.
During your second visit, you will meet with an exercise physiologist, a specially-trained health care professional who will design a personalized exercise program for you, that will involve walking (up to 30 minutes) on most days of the week. If walking is difficult or painful for you, another form of exercise will be substituted. In addition to receiving a personalized exercise program, you will also receive telephone counseling between your visits to M. D. Anderson and printed materials. Both will provide information and support for your exercise program. The telephone counseling calls will take place once a week during the first 2 months, every other week during Months 3 and 4, and once a month during Months 5 and 6. The phone counselor will talk to you about your exercise program and how it is working for you. The telephone calls will take place at a time that is convenient to you, and will take about 15-20 minutes each time. Some of these telephone counseling calls may be audiotaped, so that the counselors' supervisors can make sure the counseling is done correctly.
During each of the 2-month, 4-month, and 6-month clinic visits (Visits 3, 4, and 5), you will do another fitness test, and any necessary adjustments to your exercise program will be made. This means that if the goals for exercise were set too high or too low, how often the exercise occurs or how long each exercise session lasts will be changed. For example, if the exercise physiologist first recommended that you walk for 15 minutes a day 5 days a week, but you report that you can't walk for 15 minutes, the length of the walk may be reduced. You will also fill out the questionnaires and do the tasks on the computer at these visits. You will complete a brief (5 minutes) program evaluation. You will also be asked to answer questions on the handheld computer for 5 days before and after each these visits. You will also be asked to wear the Actigraph for 5 days before and after each of these visits. At the last visit, you will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days. The study staff will give you a prepaid mailing envelopes so you can return the computer, the Actigraph, and the package of vials to them by mail, after the last 5-day period.
This is an investigational study. Up to 326 participants will be enrolled for this study. For the pilot phase, which has been completed, 22 endometrial cancer survivors and 37 comparison participants with no history of cancer were enrolled. For the main phase of the study, for which you are enrolling, up to 267 endometrial cancer survivors will be enrolled. All will be enrolled at M. D. Anderson.
- Conditions
- Endometrial Cancer
- Being tested
- Personalized Exercise Program, Questionnaire, Suggested Exercise Program
- Keywords
- Endometrial Cancer, Healthy Controls, Social Cognitive Theory, Behavioral Intervention, Physical Activity, Exercise Program, Questionnaire
- Medical subject headings
- Endometrial Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Exercise ProgramBehavioural
Walking up to thirty minutes on most days of the week.
QuestionnaireBehavioural
Also called Survey
Questionnaires regarding physical activity, exercise, and quality of life.
Suggested Exercise ProgramBehavioural
Exercise program performed over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1: Endometrial Cancer Survivors | Not described Receives: Behavioral: Personalized Exercise Program; Behavioral: Questionnaire | |
| 2: Healthy Participants | Healthy participants that have no history of invasive cancer. Receives: Behavioral: Questionnaire; Behavioral: Suggested Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity adoption and adherence in endometrial cancer survivors
Measured: Assessments will take place every 2 months, for 4 assessments over a 6-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startMay 2005
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501761
- Sponsor's protocol ID
- 2004-0454
- Other IDs
- 1R01CA109919-01
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2007
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Robertson MC, Lyons EJ, Song J, Cox-Martin M, Li Y, Green CE, Pinto BM, Carmack CL, Harrison C, Baum G, Basen-Engquist KM. Change in physical activity and quality of life in endometrial cancer survivors receiving a physical activity intervention. Health Qual Life Outcomes. 2019 May 27;17(1):91. doi: 10.1186/s12955-019-1154-5.
PubMed 31133040
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognitive Theory and Physical Activity After Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00501761
- Acronym / sponsor ID
- 2004-0454
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Healthy Controls, Social Cognitive Theory, Behavioral Intervention, Physical Activity, Exercise Program, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2005 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Jul 2007 (estimated)
- 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.
Researchers propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical activity intervention.
The specific aims of the study are:
- To test a Social Cognitive Theory-based model of physical activity adoption among sedentary endometrial cancer survivors receiving an intervention to increase physical activity. The model includes hypotheses about the effect of self-efficacy and outcome expectations on physical activity adherence, the effects of four sources of efficacy information (mastery experience, verbal persuasion, modeling, and physiological feedback) on self-efficacy and subsequent exercise adherence, and the influence of physical activity outcomes on subsequent self-efficacy, outcome expectations, and physical activity.
- To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
- To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
- To test the effects of adherence to physical activity on endometrial cancer survivors' quality of life and stress as assessed by self-report and salivary cortisol.
- To test the feasibility of a web-based maintenance intervention for women who have completed the phone counseling portion of the study.
Detailed description
Women who have been successfully treated for endometrial cancer will be invited to participate in the study. After you agree to participate you will be asked questions about your physical activity to make sure you are eligible. You will only be allowed to participate in this study if your physician feels it is safe for you to engage in moderate physical activity, so you will be asked to have him or her complete a form about your health conditions. Information about you cancer and treatment history will be collected from your medical records as part of the study.
If you agree to take part in this study, you will come to M. D. Anderson for study visits twice at the beginning of the study. If needed, the activities for these first 2 visits can be combined into 1 visit, though it will mean that the single visit will take a little longer than each of the 2 visits. After the first visit, you will be asked to return after 2, 4, and 6 months. Each visit will take about 2 hours. Three (3) months and 6 months after the last visit, you will be called to answer questions about your physical activity. It will take about 10 minutes to answer the questions. In case you cannot be reached by phone, the questionnaires will be mailed to you. You will be asked to mail the questionnaire back in with a pre-paid addressed envelope.
At the first visit you will complete questionnaires about your quality of life, medical conditions, and how physically active you are currently and have been in the past. The questionnaires will take about 45 minutes to complete. A baseline electrocardiogram (ECG-a test to measure the electrical activity of the heart) will be performed. If your ECG test is not normal you will be informed. You will practice using the exercise bicycle that will be used in the fitness testing at the later visits. You will be asked to provide a saliva sample by placing a cotton roll in your mouth until it is saturated and then placing it back in a plastic vial without using your hands. This sample will be for practice and will be discarded.
You will also be given an ActiGraph to wear for 5 days. This is a small light device that you wear on your waist during the day. It records how active you are. You will also be given a handheld computer that you will use for 5 days to answer questions about physical activity. The computers are small (about 4-1/2 by 3 inches) and light (about 4 1/2 ounces). The computer will prompt you to enter information up to 8 times a day. Answering these questions will take up to 5 minutes. You will be asked to return the Actigraph and the computer on your second visit.
After 5 days, you will come back to M. D. Anderson for your second study visit. During this visit, you will be asked to complete questionnaires about physical activity that will take about 1 hour. You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart) performed. You will perform a fitness test, in which you will ride a stationary bicycle while your heart rate, blood pressure, and respiration (breathing) are monitored. You will also be asked to complete two tasks on a computer. After the second visit, you will again use the handheld computer and wear an Actigraph for 5 days. You will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days.
During your second visit, you will meet with an exercise physiologist, a specially-trained health care professional who will design a personalized exercise program for you, that will involve walking (up to 30 minutes) on most days of the week. If walking is difficult or painful for you, another form of exercise will be substituted. In addition to receiving a personalized exercise program, you will also receive telephone counseling between your visits to M. D. Anderson and printed materials. Both will provide information and support for your exercise program. The telephone counseling calls will take place once a week during the first 2 months, every other week during Months 3 and 4, and once a month during Months 5 and 6. The phone counselor will talk to you about your exercise program and how it is working for you. The telephone calls will take place at a time that is convenient to you, and will take about 15-20 minutes each time. Some of these telephone counseling calls may be audiotaped, so that the counselors' supervisors can make sure the counseling is done correctly.
During each of the 2-month, 4-month, and 6-month clinic visits (Visits 3, 4, and 5), you will do another fitness test, and any necessary adjustments to your exercise program will be made. This means that if the goals for exercise were set too high or too low, how often the exercise occurs or how long each exercise session lasts will be changed. For example, if the exercise physiologist first recommended that you walk for 15 minutes a day 5 days a week, but you report that you can't walk for 15 minutes, the length of the walk may be reduced. You will also fill out the questionnaires and do the tasks on the computer at these visits. You will complete a brief (5 minutes) program evaluation. You will also be asked to answer questions on the handheld computer for 5 days before and after each these visits. You will also be asked to wear the Actigraph for 5 days before and after each of these visits. At the last visit, you will also be given 10 vials with a container bag and instructions on collecting saliva samples. You will be asked to provide saliva samples 5 times per day for 2 consecutive days. The study staff will give you a prepaid mailing envelopes so you can return the computer, the Actigraph, and the package of vials to them by mail, after the last 5-day period.
This is an investigational study. Up to 326 participants will be enrolled for this study. For the pilot phase, which has been completed, 22 endometrial cancer survivors and 37 comparison participants with no history of cancer were enrolled. For the main phase of the study, for which you are enrolling, up to 267 endometrial cancer survivors will be enrolled. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Endometrial Cancer Survivors | – | Behavioral: Personalized Exercise Program, Behavioral: Questionnaire |
| 2: Healthy Participants | – | Behavioral: Questionnaire, Behavioral: Suggested Exercise ProgramHealthy participants that have no history of invasive cancer. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants that have survived endometrial cancer and healthy participants that have no history of invasive cancer.
Key inclusion criteria (12 listed)
- Survivor of endometrial cancer (survivor group only).
- Was diagnosed with Stage I, II, or IIIa endometrial cancer in the past five years (survivor group only).
- Completed surgical or radiation treatment at least 6 months ago (survivor group only).
- No history of invasive cancer, except for non-melanoma skin cancer (no cancer history group).
- Age 45 years of older (no cancer history group).
Key exclusion criteria (7 listed)
- Engages in programmatic physical activity at moderate or greater intensity on five or more days per week for 30 minutes or more, or vigorous intensity activity 20 minutes or more at least 3 days per week, and have maintained this level of activity for six months or longer.
- Have any condition defined by the American College of Sports Medicine's as "absolute contraindications to exercise testing" (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection).
- Have any condition as defined by the American College of Sports Medicine's as "relative contraindications to exercise testing" (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease).
- Right or left bundle branch block.
- Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
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 |
|---|---|---|
| Personalized Exercise ProgramWalking up to thirty minutes on most days of the week. | Behavioural | 1: Endometrial Cancer Survivors |
| QuestionnaireAlso: SurveyQuestionnaires regarding physical activity, exercise, and quality of life. | Behavioural | 1: Endometrial Cancer Survivors, 2: Healthy Participants |
| Suggested Exercise ProgramExercise program performed over 7 days. | Behavioural | 2: Healthy Participants |
Primary outcome
Physical activity adoption and adherence in endometrial cancer survivors
Time frame: Assessments will take place every 2 months, for 4 assessments over a 6-month period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Derived from this study: PubMed 31133040Robertson MC, Lyons EJ, Song J, Cox-Martin M, Li Y, Green CE, Pinto BM, Carmack CL, Harrison C, Baum G, Basen-Engquist KM. Change in physical activity and quality of life in endometrial cancer survivors receiving a physical activity intervention. Health Qual Life Outcomes. 2019 May 27;17(1):91. doi: 10.1186/s12955-019-1154-5.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Karen Basen-Engquist, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 12 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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?
Physical activity adoption and adherence in endometrial cancer survivors (time frame: Assessments will take place every 2 months, for 4 assessments over a 6-month period.). 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 NCT00501761, which also lists 1 linked publication.
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 31 Dec 2020.