Medication AdherencePhase 3TENNNCT01596179
Technology Enhanced Nurse Navigator Trial (TENN Trial)
A Phase 3 study testing Interactive navigational support and Internet access in people with Medication Adherence, run by Mercy Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Interactive navigational support and Internet access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking
- Enrolled in a case management program.
- Unable to sign an informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Prevention and Research Center at Mercy Medical Center
Baltimore, Maryland, 21202
About this study
Official title: Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Interactive navigational support, Internet access
- Keywords
- treatment adherence, fatigue, symptom management
- Medical subject headings
- Medication Adherence, Treatment Adherence and Compliance, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive navigational supportBehavioural
Interactive navigational support is provided by a nurse and social worker navigators
Internet accessBehavioural
a netbook computer with internet access is provided to participants on the control arm.
| Study group | Role | What they receive |
|---|---|---|
| Interactive navigational support | Experimental | 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. Receives: Behavioral: Interactive navigational support |
| control arm | Active comparator | 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. Receives: Behavioral: Internet access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 months and 12 months
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).
Measured: Baseline, 6 months and 12 months
Secondary outcomes (2)
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).
Measured: Baseline, 6 months and 12 months
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
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Maryland Department of Health and Mental Hygiene
- Responsible party
- Sponsor
- Investigators
- Kathy Helzlsouer, M.D., M.H.S., Principal investigator, The Prevention and Research Center at Mercy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596179
- Sponsor's protocol ID
- MMC2011-001
- Acronym
- TENN
- Status last verified
- Jan 2015
- First submitted
- 8 May 2012
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01596179
- Acronym / sponsor ID
- TENN / MMC2011-001
- Conditions
- Medication Adherence
- Keywords
- treatment adherence, fatigue, symptom management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Maryland Department of Health and Mental Hygiene
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive navigational support | Experimental | Behavioral: Interactive navigational supportPatients 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. |
| control arm | Active comparator | Behavioral: Internet accessPatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Non-English speaking
- Enrolled in a case management program.
- Unable to sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive navigational supportInteractive navigational support is provided by a nurse and social worker navigators | Behavioural | Interactive navigational support |
| Internet accessa netbook computer with internet access is provided to participants on the control arm. | Behavioural | control arm |
Primary outcome
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).
2 secondary outcomes
Patient satisfaction
Time frame: Baseline, 6 months and 12 months
Quality of life
Time frame: Baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
Related trials for Medication Adherence
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Helzlsouer, M.D., M.H.S. principal investigator
The Prevention and Research Center at Mercy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interactive navigational support and Internet access in people with Medication Adherence, run by Mercy Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: Baseline, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.