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Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials

25 gennaio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

418

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Diego, California, Stati Uniti, 92182
        • San Diego State University
    • Florida
      • Tampa, Florida, Stati Uniti, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Hawaii MU-NCORP
    • Illinois
      • Decatur, Illinois, Stati Uniti, 62526
        • Heartland NCORP
    • Kansas
      • Prairie Village, Kansas, Stati Uniti, 66208
        • Kansas City Clinical Oncology Program
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Gulf South MU-NCORP
    • Michigan
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Cancer Research Consortium of West Michigan
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55426
        • Metro MN NCORP
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Nevada Cancer Research Foundation NCORP
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Nevada NCORP
    • New York
      • Rochester, New York, Stati Uniti, 14642
        • URCC / University of Rochester NCORP Research Base
    • North Carolina
      • Winston-Salem, North Carolina, Stati Uniti, 27104
        • Southeast Clinical Oncology Research Consortium
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43215
        • Columbus NCORP
      • Dayton, Ohio, Stati Uniti, 45420
        • Dayton Community Oncology Program
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Geisinger Cancer Institute NCORP
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29615
        • Greenville Health System Cancer Instutite/Greenville NCORP
    • Wisconsin
      • Marshfield, Wisconsin, Stati Uniti, 54449
        • Wisconsin NCORP
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Aurora NCORP

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: print educational intervention
print educational intervention
Altri nomi:
  • intervento, educativo
Sperimentale: 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.
Comportamentale: multimedia psychoeducational intervention
multimedia psychoeducational intervention
Altri nomi:
  • intervento, educativo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Decision Regret Scale (DRS)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gary Morrow

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Paul Jacobsen, University of Rochester

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2014

Completamento primario (Effettivo)

31 agosto 2016

Completamento dello studio (Effettivo)

1 novembre 2016

Date di iscrizione allo studio

Primo inviato

31 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

31 gennaio 2014

Primo Inserito (Stima)

4 febbraio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • URCC12107 (Altro identificatore: University of Rochester)
  • U10CA037420 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2013-02237 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • URCC-12107 (Altro identificatore: DCP)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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