Colorectal CancerNCT00825240
Formative Study of Tailored Survivor Health Promotion
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
The overall goal of this study is to explore colorectal cancer patients' concerns and interest about their health and behavior changes post treatment. Investigators will conduct formative research, which includes qualitative interviews, to assess the issues that cancer survivors are willing to work on as they… 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?
- One-time Questionnaire + Recorded Qualitative Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.
Who may be able to join
- Patient with Stage IIB or III colorectal cancer.
- Men and women within 1 year of ending primary treatment for colorectal cancer.
- Over 18 years of age.
- Must be able to read and write English.
- Must be able to understand and provide written informed consent.
Who cannot join
- 1) Patients who have had previous treatment for cancer before treatment at M.D. Anderson, Kelsey-Seybold, and the VA Medical Center.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kelsey Research Foundation
Houston, Texas, 77005
The Michael E. DeBakey VA Medical Center, Baylor College of Medicine
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The overall goal of this study is to explore colorectal cancer patients' concerns and interest about their health and behavior changes post treatment. Investigators will conduct formative research, which includes qualitative interviews, to assess the issues that cancer survivors are willing to work on as they transition out of active treatment.
The specific aims are as follows:
Read more
Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion and illness prevention behavior changes for which colorectal cancer survivors need new information, skills training and support.
Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional status.
Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer patients' health goals and functional status.
Read the detailed description
Study Procedures:
If you agree to take part in this study, you will be asked to fill out a questionnaire about the your current health status, social support and goals.
After completing the questionnaire, you will have an interview with a research assistant. The interview will be audio recorded. You will be asked about goals you have for your health, what you are doing to reach those goals, resources you would like to receive, and challenges you faced since completing your treatment.
Your name and any of your other personal identifying information will not be linked to or collected with any of your responses. All audio tapes will be destroyed at the end of the study.
Length of Study :
The total time of participation for this study is about 45 minutes.
This is an investigational study. Up to 45 patients will be enrolled in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- One-time Questionnaire + Recorded Qualitative Interview
- Keywords
- Colorectal Cancer, Cancer Survivorship Study, Questionnaires, Survivorship, Survivor Health, Health Promotion, Behavior Changes, Computer-assisted intervention program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-time Questionnaire + Recorded Qualitative InterviewBehavioural
Also called surveys
One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Survivorship Study | Survey of colorectal cancer patients within one year from treatment end. Receives: Behavioral: One-time Questionnaire + Recorded Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment
Measured: Qualitative data collection over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2014
- Study completionNov 2014
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Holmes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825240
- Sponsor's protocol ID
- 2008-0296
- Status last verified
- Mar 2015
- First submitted
- 15 Jan 2009
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Study of Tailored Survivor Health Promotion
- ClinicalTrials.gov ID
- NCT00825240
- Acronym / sponsor ID
- 2008-0296
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Cancer Survivorship Study, Questionnaires, Survivorship, Survivor Health, Health Promotion, Behavior Changes, Computer-assisted intervention program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Jan 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 overall goal of this study is to explore colorectal cancer patients' concerns and interest about their health and behavior changes post treatment. Investigators will conduct formative research, which includes qualitative interviews, to assess the issues that cancer survivors are willing to work on as they transition out of active treatment.
The specific aims are as follows:
Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion and illness prevention behavior changes for which colorectal cancer survivors need new information, skills training and support.
Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional status.
Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer patients' health goals and functional status.
Detailed description
Study Procedures:
If you agree to take part in this study, you will be asked to fill out a questionnaire about the your current health status, social support and goals.
After completing the questionnaire, you will have an interview with a research assistant. The interview will be audio recorded. You will be asked about goals you have for your health, what you are doing to reach those goals, resources you would like to receive, and challenges you faced since completing your treatment.
Your name and any of your other personal identifying information will not be linked to or collected with any of your responses. All audio tapes will be destroyed at the end of the study.
Length of Study :
The total time of participation for this study is about 45 minutes.
This is an investigational study. Up to 45 patients will be enrolled in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivorship Study | – | Behavioral: One-time Questionnaire + Recorded Qualitative InterviewSurvey of colorectal cancer patients within one year from treatment end. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.
Key inclusion criteria (5 listed)
- Patient with Stage IIB or III colorectal cancer.
- Men and women within 1 year of ending primary treatment for colorectal cancer.
- Over 18 years of age.
- Must be able to read and write English.
- Must be able to understand and provide written informed consent.
Key exclusion criteria (1 listed)
- 1) Patients who have had previous treatment for cancer before treatment at M.D. Anderson, Kelsey-Seybold, and the VA Medical Center.
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 |
|---|---|---|
| One-time Questionnaire + Recorded Qualitative InterviewAlso: surveysOne-time questionnaire + recorded qualitative interview, approximately 45 minutes total. | Behavioural | Cancer Survivorship Study |
Primary outcome
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment
Time frame: Qualitative data collection over 2 years
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 9 Mar 2015.
- 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.
Holly Holmes, MD principal investigator
M.D. Anderson Cancer Center
3 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 M.D. Anderson Cancer Center at 3 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?
The sponsor lists 5 inclusion and 1 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment (time frame: Qualitative data collection over 2 years). 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 9 Mar 2015.