Formative Study of Tailored Survivor Health Promotion | NCT00825240

Studies
Formative Study of Tailored Survivor Health Promotion

NCT00825240

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Mar 9, 2015Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

One-time Questionnaire + Recorded Qualitative Interview

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jan 15, 2009

First Submission Date that Met QC Criteria

Jan 15, 2009

First Posted Date

Jan 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2015

Last Update Posted Date

Mar 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer Survivorship Study		Survey of colorectal cancer patients within one year from treatment end.	Behavioral: One-time Questionnaire + Recorded Qualitative Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
One-time Questionnaire + Recorded Qualitative Interview	Behavioral	One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.	Cancer Survivorship Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment		Qualitative data collection over 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holly Holmes, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kelsey Research Foundation		Houston	Texas	77005	United States
The Michael E. DeBakey VA Medical Center, Baylor College of Medicine

References Module

Citations

Not provided

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms