Technology and Navigation to Improve Survivorship Care

May 23, 2019 updated by: M.D. Anderson Cancer Center

Integrating Technology and Navigation to Improve Survivorship Care in Underserved Populations

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

80

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
    • Texas
      • Houston, Texas, United States, 77026
        • Lyndon B. Johnson Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer survivors and stakeholders at LBJ General Hospital Cancer Survivorship Clinic in Houston, Texas

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Survivors
Patients in the LBJ General Hospital Cancer Survivorship Clinic.
Behavioral: Audio Recorded Interviews
Audio recorded interview at beginning of visit and after using HealthATM website.
Other: Website Session
10-15 minute session with the HealthATM website.
Behavioral: Questionnaire
Questionnaire completion at end of audio recorded interview taking about 5 minutes.
Other Names:
  • Survey
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).
Behavioral: Audio Recorded Interviews
Audio recorded interview at beginning of visit and after using HealthATM website.
Other: Website Session
10-15 minute session with the HealthATM website.
Behavioral: Focus Group Session
Focus group session taking 60-90 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview Study of Breast Cancer Survivorship Programs Using Technology
Time Frame: 1 day
Breast cancer survivors and clinic staff surveys analyzed regarding acceptability of, and preferences for integration of patient navigation and an eHealth technology platform. Focus group and interview transcripts analyzed using ATLAS.ti qualitative analysis software. To analyze these data, constant comparative method used to conduct thematic analysis of transcribed data. As secondary check of breast cancer survivor data, calculation of descriptive statistics for measures administered to survivors following interview (frequencies, means, and standard deviations) including Patient Activation Measure and Systems Usability Scale.
1 day

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Susan Peterson, MPH, PhD, M.D. Anderson 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

February 1, 2013

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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