Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
25. januar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
418
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
San Diego, California, Forenede Stater, 92182
- San Diego State University
-
-
Florida
-
Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96813
- Hawaii MU-NCORP
-
-
Illinois
-
Decatur, Illinois, Forenede Stater, 62526
- Heartland NCORP
-
-
Kansas
-
Prairie Village, Kansas, Forenede Stater, 66208
- Kansas City Clinical Oncology Program
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70112
- Gulf South MU-NCORP
-
-
Michigan
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Cancer Research Consortium of West Michigan
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55426
- Metro MN NCORP
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, Forenede Stater, 89106
- Nevada NCORP
-
-
New York
-
Rochester, New York, Forenede Stater, 14642
- URCC / University of Rochester NCORP Research Base
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27104
- Southeast Clinical Oncology Research Consortium
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43215
- Columbus NCORP
-
Dayton, Ohio, Forenede Stater, 45420
- Dayton Community Oncology Program
-
-
Pennsylvania
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Cancer Institute NCORP
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29615
- Greenville Health System Cancer Instutite/Greenville NCORP
-
-
Wisconsin
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Wisconsin NCORP
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Aurora NCORP
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
|
|
Eksperimentel: 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 navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Day 49-56
|
|
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.
|
Day 49-56
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Day 49-56
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Paul Jacobsen, University of Rochester
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2014
Primær færdiggørelse (Faktiske)
31. august 2016
Studieafslutning (Faktiske)
1. november 2016
Datoer for studieregistrering
Først indsendt
31. januar 2014
Først indsendt, der opfyldte QC-kriterier
31. januar 2014
Først opslået (Skøn)
4. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- URCC12107 (Anden identifikator: University of Rochester)
- U10CA037420 (U.S. NIH-bevilling/kontrakt)
- NCI-2013-02237 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- URCC-12107 (Anden identifikator: DCP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .