Technology Enhanced Nurse Navigator Trial (TENN Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mercy Medical Center
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Maryland Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Mercy Medical Center
ClinicalTrials.gov Identifier:
NCT01596179
First received: May 8, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Medication Adherence
Behavioral: Interactive navigational support
Behavioral: Internet access
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mercy Medical Center:

Primary Outcome Measures:
  • Treatment Adherence [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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).

  • Fatigue [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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).

  • Quality of life [ Time Frame: Baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interactive navigational support
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.
Behavioral: Interactive navigational support
Interactive navigational support is provided by a nurse and social worker navigators
Active Comparator: control arm
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.
Behavioral: Internet access
a netbook computer with internet access is provided to participants on the control arm.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596179

Contacts
Contact: Shannon S Manocheh 4103324945 smanoche@mdmercy.com
Contact: Kaitlyn Kortokrax 4109517950 kkorto@mdmercy.com

Locations
United States, Maryland
The Prevention and Research Center at Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Principal Investigator: Kathy Helzlsouer, MD, MHS         
Sub-Investigator: Sue Appling, PhD, MS,CRNP         
Sub-Investigator: Susan Scarvalone, MSW, LCSW         
Sponsors and Collaborators
Mercy Medical Center
Susan G. Komen Breast Cancer Foundation
Maryland Department of Health and Mental Hygiene
Investigators
Principal Investigator: Kathy Helzlsouer, M.D., M.H.S. The Prevention and Research Center at Mercy Medical Center
  More Information

No publications provided

Responsible Party: Mercy Medical Center
ClinicalTrials.gov Identifier: NCT01596179     History of Changes
Other Study ID Numbers: MMC2011-001
Study First Received: May 8, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mercy Medical Center:
treatment adherence
fatigue
symptom management

ClinicalTrials.gov processed this record on July 22, 2014