Breast CancerNCT01663870
Technology and Navigation to Improve Survivorship Care
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Audio Recorded Interviews, Focus Group Session and Website Session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer survivors and stakeholders at LBJ General Hospital Cancer Survivorship Clinic in Houston, Texas
Who may be able to join
- 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
Who cannot join
- 1) None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Audio Recorded Interviews, Focus Group Session, Website Session, Questionnaire
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio Recorded InterviewsBehavioural
Audio recorded interview at beginning of visit and after using HealthATM website.
Focus Group SessionBehavioural
Focus group session taking 60-90 minutes.
Website SessionOther
10-15 minute session with the HealthATM website.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion at end of audio recorded interview taking about 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Patients in the LBJ General Hospital Cancer Survivorship Clinic. Receives: Behavioral: Audio Recorded Interviews; Other: Website Session; Behavioral: 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). Receives: Behavioral: Audio Recorded Interviews; Behavioral: Focus Group Session; Other: Website Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, MPH, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663870
- Sponsor's protocol ID
- 2012-0450
- Status last verified
- May 2019
- First submitted
- 8 Aug 2012
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Technology and Navigation to Improve Survivorship Care in Underserved Populations
- ClinicalTrials.gov ID
- NCT01663870
- Acronym / sponsor ID
- 2012-0450
- Conditions
- Breast Cancer
- Keywords
- Cancer Prevention, Breast cancer survivors, Cancer survivorship clinic, eHealth technology, Internet, HealthATM website, Questionnaire, Clinic stakeholders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Behavioral: Audio Recorded Interviews, Other: Website Session, Behavioral: QuestionnairePatients in the LBJ General Hospital Cancer Survivorship Clinic. |
| Clinic Stakeholders | – | Behavioral: Audio Recorded Interviews, Behavioral: Focus Group Session, Other: Website SessionSurvivorship 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors and stakeholders at LBJ General Hospital Cancer Survivorship Clinic in Houston, Texas
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- 1) None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio Recorded InterviewsAudio recorded interview at beginning of visit and after using HealthATM website. | Behavioural | Breast Cancer Survivors, Clinic Stakeholders |
| Focus Group SessionFocus group session taking 60-90 minutes. | Behavioural | Clinic Stakeholders |
| Website Session10-15 minute session with the HealthATM website. | Other | Breast Cancer Survivors, Clinic Stakeholders |
| QuestionnaireAlso: SurveyQuestionnaire completion at end of audio recorded interview taking about 5 minutes. | Behavioural | Breast Cancer Survivors |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Peterson, MPH, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview Study of Breast Cancer Survivorship Programs Using Technology (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.