Technology Enhanced Nurse Navigator Trial (TENN Trial)
TENN
1 other identifier
interventional
101
1 country
1
Brief Summary
The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the best way to provide breast cancer patients with information through a computer connected to the internet. The study will determine if giving information during treatment may help patients cope better with their treatment. The hypothesis is that participants assigned to receive Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to treatment regimens and have improved symptom management than women who have access to the education portal only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2012
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 17, 2015
January 1, 2015
3 years
May 8, 2012
April 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment Adherence
Adherence will be determined by review of the claims data. All claims, including hormone, chemotherapy and radiation therapy, doctor's visits, and hospitalizations, are sent through the BCCDT program. For chemotherapy and radiation therapy, relative dose intensity (RDI) will be measured. Adherence to hormone therapy will be measured as the medication possession ratio (MPR).A self-reported measure of adherence will be correlated with these more objective measures (Morisky et al. 1986).
Baseline, 6 months and 12 months
Fatigue
Fatigue will be measured using a visual analogue scale. The FACT-B will be used to measure quality of life. The FACT-B is the Functional Assessment of Cancer Therapy-Breast, a reliable and valid measure for assessing subjective health-related quality of life among breast cancer survivors (Brady et al. 1997). The FACT-B includes both the FACT-General (FACT-G) and the Breast Cancer Subscale (BCS). The FACT-B has shown high internal consistency with a Cronbach's alpha of 0.90 (Brady et al. 1997).
Baseline, 6 months and 12 months
Secondary Outcomes (2)
Patient satisfaction
Baseline, 6 months and 12 months
Quality of life
Baseline, 6 months and 12 months
Study Arms (2)
Interactive navigational support
EXPERIMENTALPatients on the intervention arm are provided with a netbook computer and internet access with ongoing interaction with a nurse and a social worker navigators for a one year period.
control arm
ACTIVE COMPARATORPatients on the control arm are provided with a netbook computer, internet access and general website information but no interactive navigational support for a one year period.
Interventions
Interactive navigational support is provided by a nurse and social worker navigators
a netbook computer with internet access is provided to participants on the control arm.
Eligibility Criteria
You may qualify if:
- Enrolled in the BCCDT program for the adjuvant treatment of breast cancer,currently on medical assistance,or with an income that does not exceed 300% of the Federal Poverty Level, based on family size.
- English-speaking
- Able to give informed consent
- Not enrolled in another case-management program
- Residing within the Verizon 3G Coverage area
You may not qualify if:
- Non-English speaking
- Enrolled in a case management program.
- Unable to sign an informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Medical Centerlead
- Susan G. Komen Breast Cancer Foundationcollaborator
- Maryland Department of Health and Mental Hygienecollaborator
Study Sites (1)
The Prevention and Research Center at Mercy Medical Center
Baltimore, Maryland, 21202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Helzlsouer, M.D., M.H.S.
The Prevention and Research Center at Mercy Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 10, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 17, 2015
Record last verified: 2015-01