Technology Enhanced Nurse Navigator Trial (TENN Trial) (TENN)
|ClinicalTrials.gov Identifier: NCT01596179|
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: Interactive navigational support Behavioral: Internet access||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
- Treatment Adherence [ Time Frame: Baseline, 6 months and 12 months ]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 ]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).
- Patient satisfaction [ Time Frame: Baseline, 6 months and 12 months ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596179
|United States, Maryland|
|The Prevention and Research Center at Mercy Medical Center|
|Baltimore, Maryland, United States, 21202|
|Principal Investigator:||Kathy Helzlsouer, M.D., M.H.S.||The Prevention and Research Center at Mercy Medical Center|