Technology Enhanced Nurse Navigator Trial (TENN Trial)

Medication Adherence Clinical Trial

— TENN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596179
• Other study ID #: MMC2011-001
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2012
• Last updated: April 16, 2015
• Start date: February 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2015
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Interactive navigational support
Interactive navigational support is provided by a nurse and social worker navigators
• Internet access
a netbook computer with internet access is provided to participants on the control arm.

Locations

Country	Name	City	State
United States	The Prevention and Research Center at Mercy Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Mercy Medical Center	Maryland Department of Health and Mental Hygiene, Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Patient satisfaction	As recommended by the NCI Navigation Research Program, we will include the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) designed to measure self-efficacy and positive attitude for cancer patients (Wolf et al. 2005).	Baseline, 6 months and 12 months	No
Secondary	Quality of life	As a measure of distress, we will use the Impact of Events scale revised (IES-R), an updated version of the original Impact of Events scale (IES) (Horowitz et al. 1979;Weiss et al. 1997). The IES-R is a validated measure of responses to a stressful life event and addresses distress and intrusive thoughts consistent with responses to the DSM-IV diagnosis criteria of PTSD. The IES-R is readily modified to address an event such as diagnosis of cancer or a chemotherapy-related adverse event	Baseline, 6 months and 12 months	No