Technology and Navigation to Improve Survivorship Care

NCT ID: NCT01663870

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2021-02-28

Brief Summary

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The goal of this research study to learn about breast cancer survivorship and possible ways to improve breast cancer survivorship programs using technology.

Objectives:

Objective 1: Assess breast cancer survivors on the acceptability of and preferences for the integration of patient navigation and an eHealth technology platform to improve care in the Survivorship Clinic at Lyndon B. Johnson Hospital.

Objective 2: Assess clinic stakeholders acceptability of and preferences for the integration of patient navigation and an eHealth technology platform to improve care for breast cancer patients in the Survivorship Clinic at Lyndon B. Johnson Hospital.

Detailed Description

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Breast Cancer Survivors:

If patient agrees to take part in this study, they will visit the cancer survivorship clinic where the following tests and procedures will be performed:

* Patient will have a 30-60 minute interview where they will be asked about cancer-related informational needs, feelings about survivorship care plans, and preferred methods of communication with survivorship clinic staff.
* Patient will be asked about whether they would use the internet and other technologies (such as text messages for appointment reminders) as tools in breast cancer survivorship.
* Patient will use a web-based tool called HealthATM. HealthATM is a website that is designed to provide information and tools to help patients better manage their health. After 10-15 minute session with the website, patient will be asked about how easy the website was to use and other questions about their session.
* Patient will complete a short questionnaire at the end of the interview asking about personal characteristics, how involved they are in their health care, and their attitudes towards the HealthATM website. It should take about 5 minutes to complete this questionnaire.

All interviews will be audiorecorded. All audio recordings will be kept for 5 years and then destroyed. All interview data will be stored in password-protected computers and/or locked file cabinets. There will be no personal identifying information connected to patient's interview answers.

Length of Study:

All of the study procedures will take place at one visit. The visit should last about 60 minutes.

This is an investigational study.

Up to 40 participants will be enrolled in this study. All will be enrolled at LBJ General Hospital.

Clinic Stakeholders:

If clinic staff agree to take part in this study, the following tests and procedures will be performed:

* Clinic staff will take part in a 60-90 minute focus group session where they will be asked about their feelings about survivorship care plans and if they think web-based eHealth programs would be helpful as tools in breast cancer survivorship.
* Clinic staff will be asked about any challenges and barriers they feel are facing the survivorship programs at LBJ.
* Clinic staff will use a web-based tool called HealthATM. HealthATM is a website that provides information and tools to help patients better manage their health. After a 10-15 minute session with the website, they will be asked about how easy the website was to use and other questions about their session.

All focus group sessions will be audiorecorded. All audio recordings will be kept for 5 years and then destroyed. All focus group data will be stored in password-protected computers and/or locked file cabinets. There will be no personal identifying information connected to your focus group answers.

Length of Study:

All of the study procedures will take place at one visit. The visit should last about 60 minutes.

This is an investigational study.

Up to 40 stakeholders will be enrolled in this study. All will be enrolled at LBJ General Hospital.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer Survivors

Patients in the LBJ General Hospital Cancer Survivorship Clinic.

Audio Recorded Interviews

Intervention Type BEHAVIORAL

Audio recorded interview at beginning of visit and after using HealthATM website.

Website Session

Intervention Type OTHER

10-15 minute session with the HealthATM website.

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire completion at end of audio recorded interview taking about 5 minutes.

Clinic Stakeholders

Survivorship clinic stakeholders include clinic nurses, physicians, case managers, oncology patient navigators currently working with those in active treatment, information technology support professionals from the Harris County Hospital District (HCHD).

Audio Recorded Interviews

Intervention Type BEHAVIORAL

Audio recorded interview at beginning of visit and after using HealthATM website.

Focus Group Session

Intervention Type BEHAVIORAL

Focus group session taking 60-90 minutes.

Website Session

Intervention Type OTHER

10-15 minute session with the HealthATM website.

Interventions

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Audio Recorded Interviews

Audio recorded interview at beginning of visit and after using HealthATM website.

Intervention Type BEHAVIORAL

Focus Group Session

Focus group session taking 60-90 minutes.

Intervention Type BEHAVIORAL

Website Session

10-15 minute session with the HealthATM website.

Intervention Type OTHER

Questionnaire

Questionnaire completion at end of audio recorded interview taking about 5 minutes.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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Inclusion Criteria

1. Age 18-years or older (survivors and stakeholders)
2. Ability to read and speak English or Spanish (survivors)
3. Ability to read and speak English (stakeholders)
4. Active patient at the LBJ General Hospital Survivorship Clinic (survivors only)
5. Previous cancer diagnosis with no evidence of recurrence at 3 years or greater following initial diagnosis (survivors only)
6. Harris County Hospital District employee offering clinical or administrative support to the LBJGH Cancer Survivorship Clinic (stakeholders only)
7. Cancer survivors who are at least 6 months from diagnosis

Exclusion Criteria

1\) None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Peterson, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Lyndon B. Johnson Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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2012-0450

Identifier Type: -

Identifier Source: org_study_id

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