Technology Enhanced Nurse Navigator Trial (TENN Trial)

Mercy

Status and phase: Completed; Phase 3

Conditions: Medication Adherence

Treatments: Behavioral: Interactive navigational support; Behavioral: Internet access

Study type: Interventional

Funder types: Other

Identifiers

NCT01596179

MMC2011-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Interactive navigational support

Experimental group

Description:

Patients 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.

Treatment:

Behavioral: Interactive navigational support

control arm

Active Comparator group

Description:

Patients 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.

Treatment:

Behavioral: Internet access