NCT01663870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

7 years

First QC Date

August 8, 2012

Last Update Submit

May 23, 2019

Conditions

Keywords

Cancer PreventionBreast cancer survivorsCancer survivorship cliniceHealth technologyInternetHealthATM websiteQuestionnaireClinic stakeholdersClinic nursesPhysiciansCase managersOncology patient navigatorsAudio recorded interviews

Outcome Measures

Primary Outcomes (1)

  • Interview Study of Breast Cancer Survivorship Programs Using Technology

    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

Study Arms (2)

Breast Cancer Survivors

Patients in the LBJ General Hospital Cancer Survivorship Clinic.

Behavioral: Audio Recorded InterviewsOther: Website SessionBehavioral: Questionnaire

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 InterviewsBehavioral: Focus Group SessionOther: Website Session

Interventions

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

Breast Cancer SurvivorsClinic Stakeholders

Focus group session taking 60-90 minutes.

Clinic Stakeholders

10-15 minute session with the HealthATM website.

Breast Cancer SurvivorsClinic Stakeholders
QuestionnaireBEHAVIORAL

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

Also known as: Survey
Breast Cancer Survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndon B. Johnson Hospital

Houston, Texas, 77026, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Susan Peterson, MPH, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

February 1, 2013

Primary Completion

February 1, 2020

Study Completion

February 1, 2021

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations