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Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial

Phase 3
Open (Enrolling)
Medication Adherence

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Trial Information

Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial

Treatment for breast cancer has been proven to decrease death from breast cancer. The key
to the success of treatment is getting the right dose at the right time, but many women do
not receive optimum treatment. Treatment delays, missed appointments, and failure to take
medication on a regular basis lead to poorer survival from breast cancer. In a study among
low income women only 60% of women adhered to the treatment, that is, taking their
medication at least 80% of the time. Twenty percent of women, who were supposed to take 5
years of hormone treatment, had stopped their medication in the first year. Similar
problems occur with chemotherapy and radiation therapy. Many barriers interfere with
adherence to treatment, including poor symptom management, missed appointments, and
cancelled appointments. Nurse navigation can help manage and minimize symptoms, assist
with appointment reminders, and answer questions to obtain optimum breast cancer treatment.
The goal of the proposed study is to rigorously test the delivery of nurse-navigation
through a web-based knowledge and communication portal (Technology Enhanced Nurse-directed
Navigation (TENN) for its impact on treatment adherence and symptom management. The success
of this program will be measured by improved treatment adherence, health outcome measures
such as fatigue and symptom management, patient-reported quality of life, reduced distress,
and patient satisfaction.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Non-English speaking

- Enrolled in a case management program.

- Unable to sign an informed consent

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Treatment Adherence

Outcome Description:

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).

Outcome Time Frame:

Baseline, 6 months and 12 months

Safety Issue:


Principal Investigator

Kathy Helzlsouer, M.D., M.H.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Prevention and Research Center at Mercy Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

August 2014

Related Keywords:

  • Medication Adherence
  • treatment adherence
  • fatigue
  • symptom management



The Prevention and Research Center at Mercy Medical Center Baltimore, Maryland  21202