Colon CancerPhase 3NCT00230646
Promoting Physical Activity After Colorectal Cancer
A Phase 3 study testing Exercise counseling in people with Colon Cancer and Rectal Cancer, run by The Miriam Hospital at 1 site in United States.
Trial summary
Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Exercise counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Nov 2009
- Phase
- Phase 3
- 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
Inclusion Criteria:1) men and women aged >18 years, 2) completed primary and adjuvant treatment for colon or rectal cancer (Stages 1-3). To allow for adequate recovery from treatment, patients whose only treatment is surgery, will be eligible for study participation 12 weeks after surgery and remain eligible for 2 years. Patients who have received chemotherapy or radiation will become eligible 8 weeks after treatment completion, and will remain eligible up to 2 years posttreatment. 3) <2 years since treatment completion, 4) able to read and speak English, 5) provide consent for medical chart review, 6) able to walk unassisted, 7) sedentary which will be defined as: currently not exercising for >30 mins. of moderate-intensity activity on >2 days per week or >20 mins. of vigorous activity one or more days per week over the past 6 months, and 8) have access to a telephone.
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Exclusion Criteria:Diabetes, hyperlipidemia and uncontrolled hypertension. Patients who have a positive cardiac history (myocardial infarction, angina, peripheral vascular disease, claudication, transient ischemic attacks, claudication, and past history of stroke) will be asked to obtain written permission from their cardiologist prior to study enrollment.
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Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Behavioral and Preventive Medicine
Providence, Rhode Island, 02908
About this study
Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.
Read the detailed description
Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors face many physical and psychosocial sequelae including second cancers, adverse effects on major organs, cognitive, and sexual function, problems in work and social roles and reduced quality of life. Following adjuvant treatments (chemotherapy and/or radiation), these individuals may be at increased risk for cardiovascular disease, obesity, osteoporosis and future cancers. There is growing evidence that moderate-intensity physical activity can improve physical functioning, reduce fatigue, enhance vigor and improve body esteem among those treated for breast cancer. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. The program, based on our prior work among breast cancer survivors, consists of telephone-delivered physical activity counseling over three months. The counseling is based on the Transtheoretical Model, Social Cognitive Theory and elements of Motivational Interviewing. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Exercise counseling
- Keywords
- cancer recovery, physical activity
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).
Secondary outcomes (2)
Examine the effects of the intervention on survivors' physical functioning, fitness, vigor, fatigue and body esteem at 3 months.
Examine the maintenance of outcomes (minutes of moderate intensity activity, physical functioning, vigor, fatigue and body esteem) at 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2009
- Study completionNov 2009
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 Colon CancerStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bernardine M Pinto, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230646
- Sponsor's protocol ID
- CA101770
- Status last verified
- Sep 2005
- First submitted
- 29 Sep 2005
- Last updated
- 5 Oct 2010
- Results posted
- No
Publications
Kindred MM, Pinto BM, Dunsiger SI. Association of Body Esteem with Fitness and Body Fat Among Colorectal Cancer Survivors: Secondary Analyses from a Randomized Trial. Int J Behav Med. 2019 Dec;26(6):619-628. doi: 10.1007/s12529-019-09819-x.
PubMed 31650480
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity After Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00230646
- Acronym / sponsor ID
- CA101770
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- cancer recovery, physical activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 3 Oct 2005 (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.
Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.
Detailed description
Colorectal cancer is the third most common cancer in the U.S. and if detected early, has a favorable prognosis. Colorectal cancer survivors face many physical and psychosocial sequelae including second cancers, adverse effects on major organs, cognitive, and sexual function, problems in work and social roles and reduced quality of life. Following adjuvant treatments (chemotherapy and/or radiation), these individuals may be at increased risk for cardiovascular disease, obesity, osteoporosis and future cancers. There is growing evidence that moderate-intensity physical activity can improve physical functioning, reduce fatigue, enhance vigor and improve body esteem among those treated for breast cancer. Colorectal cancer survivors report increased fatigue, low vigor, impaired physical functioning and disturbances in body esteem. However, the group is relatively understudied and the potential benefits of increased physical activity to their recovery have not been examined. This study focuses on enhancing recovery by offering a home-based physical activity program to patients who have completed treatment for colorectal cancer. The program, based on our prior work among breast cancer survivors, consists of telephone-delivered physical activity counseling over three months. The counseling is based on the Transtheoretical Model, Social Cognitive Theory and elements of Motivational Interviewing. This study will test the efficacy of the physical activity intervention using a randomized controlled design among 134 patients who have completed treatment for colorectal cancer in the past 2 years. Outcomes will include physical activity behavior, fitness, vigor, fatigue, physical functioning, and body esteem among participants at baseline, 3 (posttreatment), 6 and 12 months. We will also track intervention costs and conduct exploratory analyses of moderators and mediators of change to help guide the future development of physical activity interventions to enhance recovery from colorectal cancer.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 counseling | Behavioural | – |
Primary outcome
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).
2 secondary outcomes
Examine the effects of the intervention on survivors' physical functioning, fitness, vigor, fatigue and body esteem at 3 months.
Examine the maintenance of outcomes (minutes of moderate intensity activity, physical functioning, vigor, fatigue and body esteem) at 6 and 12 months.
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 5 Oct 2010.
- Derived from this study: PubMed 31650480Kindred MM, Pinto BM, Dunsiger SI. Association of Body Esteem with Fitness and Body Fat Among Colorectal Cancer Survivors: Secondary Analyses from a Randomized Trial. Int J Behav Med. 2019 Dec;26(6):619-628. doi: 10.1007/s12529-019-09819-x.
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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.
Bernardine M Pinto, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise counseling in people with Colon Cancer and Rectal Cancer, run by The Miriam Hospital 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?
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 5 Oct 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Minutes of moderate-intensity physical activity (PA) at 3 months among 134 sedentary patients who have completed treatment for colorectal cancer (CRC).. 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 NCT00230646, 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 5 Oct 2010.