Colorectal CancerNCT00966667
Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
An observational study of Colorectal Cancer, run by Rutgers, The State University of New Jersey at 14 sites in United States.
Trial summary
RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 222 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2009to 7 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer
DISEASE CHARACTERISTICS:
- Diagnosis of localized or regional colorectal cancer
- Stage I, II, or III disease
- Completed treatment within the past 6 weeks
- No previous diagnosis of colorectal cancer
PATIENT CHARACTERISTICS:
- English speaking
- No current evidence of neoplastic disease except for nonmelanoma skin cancer
- No evidence of severe cognitive impairment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
JFK Medical Center in Edison
Edison, New Jersey, 08818
Centrastate Healthcare System
Freehold, New Jersey, 07728
Robert Wood Johnson University Hospital at Hamilton
Hamilton, New Jersey, 08690
MD Anderson Cancer Center
Houston, Texas, 77030
Mountainside Hospital
Montclair, New Jersey, 07042
Morristown Medical Center
Morristown, New Jersey, 07962
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Saint Peters University Hospital
New Brunswick, New Jersey, 08903
Fox Chase Cancer Center
Philadelphia, Pennsylvania
University Medical Center at Princeton
Princeton, New Jersey, 08540
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey
Overlook Medical Center
Summit, New Jersey, 07901
About this study
Official title: Health Behaviors Among Individuals Diagnosed With Colorectal Cancer
RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.
PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors.
Secondary
- To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients.
- To identify these patients' preferences regarding diet and physical activity health promotion programs.
OUTLINE: This is a multicenter study.
Patients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined.
During each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them.
Measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.
- Conditions
- Colorectal Cancer
- Keywords
- cancer survivor, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer survivor | cancer survivor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for changing physical activity and dietary practices
Measured: 3 yrs
Outcome expectations with regard to physical activity and dietary practices
Measured: 3 yrs
Behavioral self-regulation of physical activity and dietary practices
Measured: 3 yrs
Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations)
Measured: 3 yrs
Perceived risk of CRC recurrence
Measured: 3 yrs
Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC)
Measured: 3 yrs
Receipt of healthcare provider recommendations to alter physical activity and diet
Measured: 3 yrs
Normative influences of family and friends
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startNov 2009
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
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 Rutgers, The State University of New JerseyThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Elliot Coups, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966667
- Sponsor's protocol ID
- 130901
- Other IDs
- R21CA131611, P30CA072720, K07CA133100, CDR0000653167, 0220090178
- Status last verified
- Sep 2019
- First submitted
- 26 Aug 2009
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behaviors Among Individuals Diagnosed With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00966667
- Acronym / sponsor ID
- 130901
- Conditions
- Colorectal Cancer
- Keywords
- cancer survivor, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- Nov 2009
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 27 Aug 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.
RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.
PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors.
Secondary
- To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients.
- To identify these patients' preferences regarding diet and physical activity health promotion programs.
OUTLINE: This is a multicenter study.
Patients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined.
During each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them.
Measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer survivor | – | –cancer survivor |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-efficacy for changing physical activity and dietary practices
Time frame: 3 yrs
Outcome expectations with regard to physical activity and dietary practices
Time frame: 3 yrs
Behavioral self-regulation of physical activity and dietary practices
Time frame: 3 yrs
Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations)
Time frame: 3 yrs
Perceived risk of CRC recurrence
Time frame: 3 yrs
Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC)
Time frame: 3 yrs
Receipt of healthcare provider recommendations to alter physical activity and diet
Time frame: 3 yrs
Normative influences of family and friends
Time frame: 3 yrs
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 10 Sep 2019.
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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.
Elliot Coups, PhD principal investigator
Rutgers Cancer Institute of New Jersey
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Rutgers, The State University of New Jersey at 14 sites 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 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
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?
Self-efficacy for changing physical activity and dietary practices (time frame: 3 yrs). 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?
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 10 Sep 2019.