- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02054715
Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation.
SECONDARY OBJECTIVES:
I. To determine the effect of intervention assignment on indicators of the quality of patients' decision making about clinical trial participation.
II. To examine mechanisms by which multimedia psychoeducation (MP) exerts its expected positive effects on preparedness for decision making.
TERTIARY OBJECTIVES:
I. To explore the effects of intervention assignment on clinical trial participation.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the National Cancer Institute (NCI) booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
ARM II: Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a digital video disk (DVD) and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
After completion of study, patients are followed up at 3-7 and 49-56 days.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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California
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San Diego, California, Vereinigte Staaten, 92182
- San Diego State University
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Florida
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Tampa, Florida, Vereinigte Staaten, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Hawaii
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Honolulu, Hawaii, Vereinigte Staaten, 96813
- Hawaii MU-NCORP
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Illinois
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Decatur, Illinois, Vereinigte Staaten, 62526
- Heartland NCORP
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Kansas
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Prairie Village, Kansas, Vereinigte Staaten, 66208
- Kansas City Clinical Oncology Program
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Gulf South MU-NCORP
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Michigan
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Grand Rapids, Michigan, Vereinigte Staaten, 49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55426
- Metro MN NCORP
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- Nevada Cancer Research Foundation NCORP
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- Nevada NCORP
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New York
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Rochester, New York, Vereinigte Staaten, 14642
- URCC / University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43215
- Columbus NCORP
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Dayton, Ohio, Vereinigte Staaten, 45420
- Dayton Community Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Vereinigte Staaten, 17822
- Geisinger Cancer Institute NCORP
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South Carolina
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Greenville, South Carolina, Vereinigte Staaten, 29615
- Greenville Health System Cancer Instutite/Greenville NCORP
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Wisconsin
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Marshfield, Wisconsin, Vereinigte Staaten, 54449
- Wisconsin NCORP
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Aurora NCORP
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Be able to speak and read English
- Be diagnosed with cancer
- Have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating NCI Community Oncology Research Program (NCORP) site
- Have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
- Be capable of providing written informed consent for study participation
Exclusion Criteria:
- Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
- Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
- Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia)
- Participants must not be eligible only for phase I trial; these patients are excluded because few of these trials are offered at NCORP sites and because their design and goals differ considerably from those of phase II and III trials
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Arm I (print educational)
Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
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print educational intervention
Andere Namen:
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Experimental: Arm II (multimedia psychoeducational)
Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
|
multimedia psychoeducational intervention
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
Zeitfenster: Day 3 to 7
|
Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision.
Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal.
Larger number is better.
All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).
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Day 3 to 7
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The Decision Regret Scale (DRS)
Zeitfenster: Day 49-56
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The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree).
A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five.
The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret.
Higher scores are worse.
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Day 49-56
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The Decisional Conflict Scale (DCS)
Zeitfenster: Day 49-56
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The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision.
In the present study, it will be keyed to the decision about therapeutic clinical trial participation.
Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale.
Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict.
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Day 49-56
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Zeitfenster: Day 49-56
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Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates.
To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.
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Day 49-56
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Paul Jacobsen, University of Rochester
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- URCC12107 (Andere Kennung: University of Rochester)
- U10CA037420 (US NIH Stipendium/Vertrag)
- NCI-2013-02237 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- URCC-12107 (Andere Kennung: DCP)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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