Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
25. januar 2021 oppdatert av: Gary Morrow
Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation.
Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation.
It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
418
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Diego, California, Forente stater, 92182
- San Diego State University
-
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Florida
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Tampa, Florida, Forente stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
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Hawaii
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Honolulu, Hawaii, Forente stater, 96813
- Hawaii MU-NCORP
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Illinois
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Decatur, Illinois, Forente stater, 62526
- Heartland NCORP
-
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Kansas
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Prairie Village, Kansas, Forente stater, 66208
- Kansas City Clinical Oncology Program
-
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Gulf South MU-NCORP
-
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Michigan
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Grand Rapids, Michigan, Forente stater, 49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55426
- Metro MN NCORP
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Nevada Cancer Research Foundation NCORP
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Las Vegas, Nevada, Forente stater, 89106
- Nevada NCORP
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New York
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Rochester, New York, Forente stater, 14642
- URCC / University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus, Ohio, Forente stater, 43215
- Columbus NCORP
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Dayton, Ohio, Forente stater, 45420
- Dayton Community Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Geisinger Cancer Institute NCORP
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Greenville Health System Cancer Instutite/Greenville NCORP
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Wisconsin
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Marshfield, Wisconsin, Forente stater, 54449
- Wisconsin NCORP
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Milwaukee, Wisconsin, Forente stater, 53226
- Aurora NCORP
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
print educational intervention
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
Tidsramme: 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).
|
Day 3 to 7
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Decision Regret Scale (DRS)
Tidsramme: Day 49-56
|
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)
Tidsramme: Day 49-56
|
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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Tidsramme: Day 49-56
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Paul Jacobsen, University of Rochester
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2014
Primær fullføring (Faktiske)
31. august 2016
Studiet fullført (Faktiske)
1. november 2016
Datoer for studieregistrering
Først innsendt
31. januar 2014
Først innsendt som oppfylte QC-kriteriene
31. januar 2014
Først lagt ut (Anslag)
4. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- URCC12107 (Annen identifikator: University of Rochester)
- U10CA037420 (U.S. NIH-stipend/kontrakt)
- NCI-2013-02237 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- URCC-12107 (Annen identifikator: DCP)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .