Clinical trial NCT01663870: Technology and Navigation to Improve Survivorship Care
Official title: Integrating Technology and Navigation to Improve Survivorship Care in Underserved Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Cancer Prevention
Breast cancer survivors
Cancer survivorship clinic
eHealth technology
Internet
HealthATM website
Questionnaire
Clinic stakeholders
Clinic nurses
Physicians
Case managers
Oncology patient navigators
Audio recorded interviews
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors and stakeholders at LBJ General Hospital Cancer Survivorship Clinic in Houston, Texas

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interview Study of Breast Cancer Survivorship Programs Using Technology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan Peterson, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: