Colorectal CancerNCT00985400
Doctor-Recommended Home-Based Exercise Program or Relaxation Training in Improving Physical Function and Controlling Symptoms in Patients With Stage IV or Recurrent Colon Cancer That Cannot Be Removed By Surgery
A study testing Exercise Program, Telephone-based intervention and Counseling intervention in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Exercise Program, Telephone-based intervention and Counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2010to 31 Mar 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
- Diagnosis of stage IV or recurrent colorectal cancer
- Age >/= 18 years
- ECOG performance status of 0 -1
- Able to communicate in English or Spanish
- Able to give informed consent
- Adequate organ function -Total bilirubin < 1.5 x the institutional upper-normal limits (IUNL); AST (SGOT) and/or ALT (SGPT) < 2.5 x IUNL; Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) < 5 x IUNL
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- Adequate bone marrow function: - Absolute neutrophil count > 1,000/microLiters; Platelets > 50,000/microLiters
- Able to ambulate without assistance
- Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.
Who cannot join
- Major surgery in the past 8 weeks
- Medical contraindications to home-based exercise as defined by the treating physician
- Symptomatic Bone Metastases
- Unstable Angina (current symptomatic angina at time of enrollment)
- Class III/IV heart failure according to NYHA classification system
- Pulmonary conditions that require oxygen
- Unable to ambulate without assistance (cane, walker, etc)
- Exercising at a moderate-vigorous intensity for 150 minutes or more per week, exercising at a vigorous intensity for more than 20 minutes on 3 or more days per week, or performing resistance exercises for more than 20 minutes per day on two or more days per week for 3 months or more.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
If you are in the exercise group, you will receive a doctor's recommendation to exercise (in-person advice and letters), newsletters on behavior change methods, resistance bands, a pedometer, and telephone counseling. A pedometer is a small device used to measure the number of steps you take.
If you are in the relaxation group, you will receive a doctor's recommendation to practice relaxation training (in-person advice and letters), newsletters on behavior change methods, written and video instructions for doing the relaxation techniques, and telephone counseling.
If you are in the Exercise Group:
- You will receive advice from your doctor (in person), physician's assistant, or other mid-level provider about exercising. You will be given advice on the use of your pedometer and resistance bands provided to you in this study, about the exercises provided and about keeping track of your progress on the exercise logs provided to you. You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be do resistance exercises using the resistance bands 2 days a week.
If you are in the Relaxation Group:
- You will receive advice from your doctor (in person), physician's assistant or other mid-level provider about relaxation techniques. You will be given advice on practicing the breathing and meditation techniques provided to you in this study, on how long and how often you are performing your relaxation techniques, and on keeping track of your relaxation practice on the relaxation logs provided to you. -You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be perform the relaxation techniques at least 15 minutes a day for 5-7 days a week.
All participants will continue the group exercises or relaxation techniques for 16 weeks.
Follow-Up Visit:
You will have a follow-up visit during Weeks 16-20. At this visit, you will complete the following tests and procedures:
- Your medical history will be recorded.
- Your performance status will be recorded.
- You will complete the 11 questionnaires.
- You will complete the exercise tests to measure how your body uses oxygen, to test your lower body strength, to test your upper body strength, and to test your flexibility and balance.
Length of Study:
You will remain on study for 16-20 weeks.
This is an investigational study.
Up to 154 patients will take part in this multicenter study. Up to 154 may be enrolled at MD Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Exercise Program, Telephone-based intervention, Counseling intervention, Questionnaire administration, Relaxation Program
- Keywords
- recurrent colon cancer, stage IV colon cancer, Gastrointestinal, Exercise, Relaxation, Meditation
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Resistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day
Telephone-based interventionBehavioural
Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.
Counseling interventionOther
Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter.
Questionnaire administrationOther
Also called Survey
Relaxation ProgramBehavioural
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | Arm I (exercise program): Oncologist advice; Resistance bands \& pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention. Receives: Behavioral: Exercise Program; Behavioral: Telephone-based intervention; Other: Counseling intervention; Other: Questionnaire administration |
| Relaxation Intervention | Experimental | Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I. Receives: Behavioral: Telephone-based intervention; Other: Counseling intervention; Other: Questionnaire administration; Behavioral: Relaxation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Measured: 3 year study period
Patient retention
Measured: 3 year study period
Program and assessment implementation
Measured: 3 year study period
Patient adherence to behavioral recommendations
Measured: Up to 20 weeks
Effect size of the exercise intervention on physical function
Measured: Up to 20 weeks
Secondary outcomes (1)
Effect size of the exercise intervention on symptoms and quality of life
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study start5 Nov 2010
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
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, Study chair, M.D. Anderson Cancer CenterMichael J. Fisch, MD, MPH, FACP, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985400
- Sponsor's protocol ID
- 2009-0288
- Other IDs
- MDA-2009-0288, CDR0000654446, NCI-2011-02280
- Status last verified
- Mar 2022
- First submitted
- 25 Sep 2009
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT00985400
- Acronym / sponsor ID
- 2009-0288
- Conditions
- Colorectal Cancer
- Keywords
- recurrent colon cancer, stage IV colon cancer, Gastrointestinal, Exercise, Relaxation, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Nov 2010 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 28 Sep 2009 (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.
The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
If you are in the exercise group, you will receive a doctor's recommendation to exercise (in-person advice and letters), newsletters on behavior change methods, resistance bands, a pedometer, and telephone counseling. A pedometer is a small device used to measure the number of steps you take.
If you are in the relaxation group, you will receive a doctor's recommendation to practice relaxation training (in-person advice and letters), newsletters on behavior change methods, written and video instructions for doing the relaxation techniques, and telephone counseling.
If you are in the Exercise Group:
- You will receive advice from your doctor (in person), physician's assistant, or other mid-level provider about exercising. You will be given advice on the use of your pedometer and resistance bands provided to you in this study, about the exercises provided and about keeping track of your progress on the exercise logs provided to you. You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be do resistance exercises using the resistance bands 2 days a week.
If you are in the Relaxation Group:
- You will receive advice from your doctor (in person), physician's assistant or other mid-level provider about relaxation techniques. You will be given advice on practicing the breathing and meditation techniques provided to you in this study, on how long and how often you are performing your relaxation techniques, and on keeping track of your relaxation practice on the relaxation logs provided to you. -You will also be given this advice in a letter.
- You will receive encouragement and support from a telephone counselor. The telephone counselor will contact you once a week for the first 4 weeks and then once a month for 12 weeks. The call will take about 5 minutes to complete.
- You will receive newsletters with stories about other cancer survivor experiences.
- You will be perform the relaxation techniques at least 15 minutes a day for 5-7 days a week.
All participants will continue the group exercises or relaxation techniques for 16 weeks.
Follow-Up Visit:
You will have a follow-up visit during Weeks 16-20. At this visit, you will complete the following tests and procedures:
- Your medical history will be recorded.
- Your performance status will be recorded.
- You will complete the 11 questionnaires.
- You will complete the exercise tests to measure how your body uses oxygen, to test your lower body strength, to test your upper body strength, and to test your flexibility and balance.
Length of Study:
You will remain on study for 16-20 weeks.
This is an investigational study.
Up to 154 patients will take part in this multicenter study. Up to 154 may be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Behavioral: Exercise Program, Behavioral: Telephone-based intervention, Other: Counseling intervention, Other: Questionnaire administrationArm I (exercise program): Oncologist advice; Resistance bands \& pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention. |
| Relaxation Intervention | Experimental | Behavioral: Telephone-based intervention, Other: Counseling intervention, Other: Questionnaire administration, Behavioral: Relaxation ProgramArm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of stage IV or recurrent colorectal cancer
- Age >/= 18 years
- ECOG performance status of 0 -1
- Able to communicate in English or Spanish
- Able to give informed consent
Key exclusion criteria (8 listed)
- Major surgery in the past 8 weeks
- Medical contraindications to home-based exercise as defined by the treating physician
- Symptomatic Bone Metastases
- Unstable Angina (current symptomatic angina at time of enrollment)
- Class III/IV heart failure according to NYHA classification system
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 |
|---|---|---|
| Exercise ProgramResistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day | Behavioural | Exercise Program |
| Telephone-based interventionPatients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks. | Behavioural | Exercise Program, Relaxation Intervention |
| Counseling interventionPatients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter. | Other | Exercise Program, Relaxation Intervention |
| Questionnaire administrationAlso: Survey | Other | Exercise Program, Relaxation Intervention |
| Relaxation ProgramRelaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week. | Behavioural | Relaxation Intervention |
Primary outcome
Recruitment rate
Time frame: 3 year study period
Patient retention
Time frame: 3 year study period
Program and assessment implementation
Time frame: 3 year study period
Patient adherence to behavioral recommendations
Time frame: Up to 20 weeks
Effect size of the exercise intervention on physical function
Time frame: Up to 20 weeks
1 secondary outcome
Effect size of the exercise intervention on symptoms and quality of life
Time frame: Up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
- University of Texas MD Anderson Cancer Center Official 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 study chair
M.D. Anderson Cancer Center
Michael J. Fisch, MD, MPH, FACP study chair
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?
A study testing Exercise Program, Telephone-based intervention and Counseling intervention in people with Colorectal 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 9 inclusion and 8 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 Mar 2022. 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?
Recruitment rate (time frame: 3 year study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2022.