NCT00825240

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

5.9 years

First QC Date

January 15, 2009

Last Update Submit

March 6, 2015

Conditions

Keywords

Colorectal CancerCancer Survivorship StudyQuestionnairesSurvivorshipSurvivor HealthHealth PromotionBehavior ChangesComputer-assisted intervention program

Outcome Measures

Primary Outcomes (1)

  • Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment

    Qualitative data collection over 2 years

Study Arms (1)

Cancer Survivorship Study

Survey of colorectal cancer patients within one year from treatment end.

Behavioral: One-time Questionnaire + Recorded Qualitative Interview

Interventions

One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.

Also known as: surveys
Cancer Survivorship Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • \) Patients who have had previous treatment for cancer before treatment at M.D. Anderson, Kelsey-Seybold, and the VA Medical Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kelsey Research Foundation

Houston, Texas, 77005, United States

Location

The Michael E. DeBakey VA Medical Center, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Holly Holmes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 19, 2009

Study Start

December 1, 2008

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations