Clinical trial NCT01596179: Technology Enhanced Nurse Navigator Trial (TENN Trial)
Official title: Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Medication Adherence
Keywords: treatment adherence
fatigue
symptom management
Lead sponsor: Mercy Medical Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: Maryland Department of Health and Mental Hygiene
First posted: 2012-05-10
Enrollment: 101
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Adherence
timeFrame: Baseline, 6 months and 12 months
measure: Fatigue
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Baseline, 6 months and 12 months
measure: Quality of life
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Prevention and Research Center at Mercy Medical Center
state: Maryland
Study officials:
affiliation: The Prevention and Research Center at Mercy Medical Center
name: Kathy Helzlsouer, M.D., M.H.S.
role: PRINCIPAL_INVESTIGATOR
References: