Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth
26 oktober 2020 uppdaterad av: Randy A. Jones, University of Virginia
Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options.
This study will test the use of an innovative Registered Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about anti-cancer treatment that affects their quality of life.
Studieöversikt
Detaljerad beskrivning
Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment.
Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers.
The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision.
The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective.
Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored.
This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center.
The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study.
Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used.
There will be two groups: the control (enhanced usual care [EUC]) group and the decision intervention (DI) group.
The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment.
Self-report measures will be used for all participants in addition to probes for the taped interviews with DI.
The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference.
Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention.
This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components.
This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.
Studietyp
Interventionell
Inskrivning (Förväntat)
316
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21205
- Rekrytering
- Johns Hopkins University
-
Kontakt:
- Jennifer Wenzel, PhD,RN,FAAN
- Telefonnummer: 410-502-1114
- E-post: jwenzel@jhu.edu
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Rekrytering
- University of Virginia
-
Kontakt:
- Randy A Jones, PhD,RN,FAAN
- Telefonnummer: 434-924-0125
- E-post: raj9c@virginia.edu
-
Kontakt:
- Jane Gildersleeve, MSN
- Telefonnummer: 434-243-3955
- E-post: jlg2g@virginia.edu
-
Richmond, Virginia, Förenta staterna, 23219
- Rekrytering
- Virginia Commonwealth University
-
Kontakt:
- Richard Brown, PhD
- Telefonnummer: 804-628-3340
- E-post: rbrown39@vcu.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 1) stages III/ IV prostate cancer 2) life expectancy ≥6 months 3) Karnofsky Performance Status >60 4) willingness of a DPP (patient selected person who provides decisional support) to participate 5) pair ages >18 years 6) ability to understand English
Exclusion Criteria:
- severe psychiatric problems
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Enhanced Usual Care
Receive standard care
|
|
|
Experimentell: Decision Intervention
Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)
|
An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Decision Conflict, Decision Regret, and Prostate Cancer Symptom Scale
Tidsram: 9 months
|
demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision
|
9 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
semi-structured interview
Tidsram: 9 months
|
evaluate community patient navigator role in delivery of decision aid
|
9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Randy A Jones, PhD,RN,FAAN, University of Virginia
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 juli 2017
Primärt slutförande (Förväntat)
31 december 2021
Avslutad studie (Förväntat)
31 december 2021
Studieregistreringsdatum
Först inskickad
26 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
26 oktober 2017
Första postat (Faktisk)
31 oktober 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 oktober 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 oktober 2020
Senast verifierad
1 oktober 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 19402
Plan för individuella deltagardata (IPD)
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NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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