Colon CancerNCT01003600
Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information
An observational study of Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
We are doing this study to learn more about colon and rectal cancer survivors. We want to know if survivors want more information about life after cancer. Do cancer survivors want to know more about their own cancer? Do cancer survivors want to know about their treatment? Do cancer survivors want to know what health… 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?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 177 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to 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: Adults who completed treatment for nonmetastatic colorectal cancer at MSKCC or at Queens Cancer Center (QCC) at Queens Hospital
Who may be able to join
- 18 years of age or older at diagnosis
- Diagnosed with first primary colorectal cancer (stage I-III)
- Completed last treatment for colorectal cancer (surgery, chemotherapy, or radiation) at least 6 months and no more than 2 years before the date of study enrollment
- Able to speak English, because questionnaire is only available in English
- Able to provide informed consent
- Received all treatment for colorectal cancer at MSKCC or QCC or, surgical treatment at an outside facility, and all other treatment (chemotherapy or radiation) at MSKCC or QCC
Who cannot join
- Undergoing active treatment for colorectal cancer
- Diagnosed with metastatic colorectal cancer
- Prior history of colorectal or any other cancer (except non-melanoma skin cancer)
- Diagnosed with new or recurrent colorectal or other cancer after the primary colorectal cancer diagnosis
- Received a survivorship care plan from the treating institution
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
We are doing this study to learn more about colon and rectal cancer survivors. We want to know if survivors want more information about life after cancer. Do cancer survivors want to know more about their own cancer? Do cancer survivors want to know about their treatment? Do cancer survivors want to know what health care they should get in the future? We want to know what information to give to cancer survivors when they finish treatment.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Questionnaire
- Keywords
- Survivorship, Quality of Life, Questionnaire, 09-133
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called The questionnaire will be administered using a Computer Assisted Telephone Interview (CATI), system. The CATI form of the questionnaire enables the interviewer to read aloud from a script and, enter responses into the computer in real-time, regardless of whether the interview is conducted on the, phone or in person. The CATI form of the questionnaire enables the interviewer to read aloud from a
The questionnaire will be administered by telephone and will take approximately 20-30 minutes. The questionnaire will elicit survivor responses along five domains: knowledge about diagnosis and treatment, knowledge about ongoing risks and recommended testing, history of health care utilization since the end of treatment, preferences for relevant information about these topics, and employment after the end of cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | This study is a cross-sectional survey study to be administered to adults who completed treatment for nonmetastatic colorectal cancer at MSKCC or at Queens Cancer Center (QCC) at Queens Hospital between 6 months and 2 years ago and have no evidence of disease at the time of study enrollment. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess colorectal cancer survivors' basic knowledge of their own cancer history, including date of diagnosis, stage, and treatments received.
Measured: 6 months to 2 years after completion of treatment
Secondary outcomes (4)
Assess survivors' knowledge of medical issues relevant to colorectal cancer survivors.
Measured: 6 months to 2 years after completion of treatment
Describe the types of health care providers that survivors have visited since completing treatment for colorectal cancer.
Measured: 6 months to 2 years after completion of treatment
Assess survivors' preferences for the content, format, and delivery of survivorship care plans.
Measured: 6 months to 2 years after completion of treatment
Assess whether survivors who had concerns about working after cancer treatment spoke with health care professionals about their concerns.
Measured: 6 months to 2 years after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startOct 2009
- 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 Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Queens Cancer Center of Queens Hospital
- Responsible party
- Sponsor
- Investigators
- Talya Salz, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003600
- Sponsor's protocol ID
- 09-133
- Status last verified
- Nov 2014
- First submitted
- 28 Oct 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information
- ClinicalTrials.gov ID
- NCT01003600
- Acronym / sponsor ID
- 09-133
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Survivorship, Quality of Life, Questionnaire, 09-133
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Queens Cancer Center of Queens Hospital
- Study start
- Oct 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Oct 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.
We are doing this study to learn more about colon and rectal cancer survivors. We want to know if survivors want more information about life after cancer. Do cancer survivors want to know more about their own cancer? Do cancer survivors want to know about their treatment? Do cancer survivors want to know what health care they should get in the future? We want to know what information to give to cancer survivors when they finish treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: QuestionnaireThis study is a cross-sectional survey study to be administered to adults who completed treatment for nonmetastatic colorectal cancer at MSKCC or at Queens Cancer Center (QCC) at Queens Hospital between 6 months and 2 years ago and have no evidence of disease at the time of study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who completed treatment for nonmetastatic colorectal cancer at MSKCC or at Queens Cancer Center (QCC) at Queens Hospital
Key inclusion criteria (6 listed)
- 18 years of age or older at diagnosis
- Diagnosed with first primary colorectal cancer (stage I-III)
- Completed last treatment for colorectal cancer (surgery, chemotherapy, or radiation) at least 6 months and no more than 2 years before the date of study enrollment
- Able to speak English, because questionnaire is only available in English
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Undergoing active treatment for colorectal cancer
- Diagnosed with metastatic colorectal cancer
- Prior history of colorectal or any other cancer (except non-melanoma skin cancer)
- Diagnosed with new or recurrent colorectal or other cancer after the primary colorectal cancer diagnosis
- Received a survivorship care plan from the treating institution
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 |
|---|---|---|
| QuestionnaireAlso: The questionnaire will be administered using a Computer Assisted Telephone Interview (CATI), system. The CATI form of the questionnaire enables the interviewer to read aloud from a script and, enter responses into the computer in real-time, regardless of whether the interview is conducted on the, phone or in person. The CATI form of the questionnaire enables the interviewer to read aloud from aThe questionnaire will be administered by telephone and will take approximately 20-30 minutes. The questionnaire will elicit survivor responses along five domains: knowledge about diagnosis and treatment, knowledge about ongoing risks and recommended testing, history of health care utilization since the end of treatment, preferences for relevant information about these topics, and employment after the end of cancer treatment. | Behavioural | Questionnaire |
Primary outcome
Assess colorectal cancer survivors' basic knowledge of their own cancer history, including date of diagnosis, stage, and treatments received.
Time frame: 6 months to 2 years after completion of treatment
4 secondary outcomes
Assess survivors' knowledge of medical issues relevant to colorectal cancer survivors.
Time frame: 6 months to 2 years after completion of treatment
Describe the types of health care providers that survivors have visited since completing treatment for colorectal cancer.
Time frame: 6 months to 2 years after completion of treatment
Assess survivors' preferences for the content, format, and delivery of survivorship care plans.
Time frame: 6 months to 2 years after completion of treatment
Assess whether survivors who had concerns about working after cancer treatment spoke with health care professionals about their concerns.
Time frame: 6 months to 2 years after completion of treatment
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 2 Dec 2014.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Talya Salz, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 2 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 6 inclusion and 5 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Assess colorectal cancer survivors' basic knowledge of their own cancer history, including date of diagnosis, stage, and treatments received. (time frame: 6 months to 2 years after completion of treatment). 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 2 Dec 2014.