Technology Enhanced Nurse Navigator Trial (TENN Trial) (TENN)
16 april 2015 bijgewerkt door: Mercy Medical Center
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
101
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21202
- The Prevention and Research Center at Mercy Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
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Interactive navigational support is provided by a nurse and social worker navigators
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Actieve vergelijker: 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.
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a netbook computer with internet access is provided to participants on the control arm.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment Adherence
Tijdsspanne: 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).
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Baseline, 6 months and 12 months
|
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Fatigue
Tijdsspanne: 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).
|
Baseline, 6 months and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient satisfaction
Tijdsspanne: 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).
|
Baseline, 6 months and 12 months
|
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Quality of life
Tijdsspanne: 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
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Baseline, 6 months and 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kathy Helzlsouer, M.D., M.H.S., The Prevention and Research Center at Mercy Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2012
Primaire voltooiing (Werkelijk)
1 februari 2015
Studie voltooiing (Werkelijk)
1 februari 2015
Studieregistratiedata
Eerst ingediend
8 mei 2012
Eerst ingediend dat voldeed aan de QC-criteria
9 mei 2012
Eerst geplaatst (Schatting)
10 mei 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
17 april 2015
Laatste update ingediend die voldeed aan QC-criteria
16 april 2015
Laatst geverifieerd
1 januari 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MMC2011-001
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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