Colorectal Cancer Survivors' Needs and Preferences for Survivorship Information

November 26, 2014 updated by: Memorial Sloan Kettering Cancer Center
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults who completed treatment for nonmetastatic colorectal cancer at MSKCC or at Queens Cancer Center (QCC) at Queens Hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Questionnaire
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.
Other Names:
  • 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
  • script and enter responses into the computer in real-time, regardless of whether the interview is
  • conducted on the phone or in person.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
6 months to 2 years after completion of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assess survivors' knowledge of medical issues relevant to colorectal cancer survivors.
Time Frame: 6 months to 2 years after completion of treatment
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
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
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
6 months to 2 years after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queens Cancer Center of Queens Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Talya Salz, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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