Technology and Navigation to Improve Survivorship Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01663870
First received: August 8, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Audio Recorded Interviews
Behavioral: Focus Group Session
Other: Website Session
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrating Technology and Navigation to Improve Survivorship Care in Underserved Populations

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Interview Study of Breast Cancer Survivorship Programs Using Technology [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.
Behavioral: Focus Group Session
Focus group session taking 60-90 minutes.
Other: Website Session
10-15 minute session with the HealthATM website.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663870

Locations
United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77026
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PHD, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01663870     History of Changes
Other Study ID Numbers: 2012-0450
Study First Received: August 8, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014