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

25 janvier 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

418

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: print educational intervention
print educational intervention
Autres noms:
  • d'intervention, d'éducation
Expérimental: 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.
Comportemental: multimedia psychoeducational intervention
multimedia psychoeducational intervention
Autres noms:
  • d'intervention, d'éducation

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The Decision Regret Scale (DRS)
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gary Morrow

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Paul Jacobsen, University of Rochester

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2014

Achèvement primaire (Réel)

31 août 2016

Achèvement de l'étude (Réel)

1 novembre 2016

Dates d'inscription aux études

Première soumission

31 janvier 2014

Première soumission répondant aux critères de contrôle qualité

31 janvier 2014

Première publication (Estimation)

4 février 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 janvier 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 janvier 2021

Dernière vérification

1 janvier 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • URCC12107 (Autre identifiant: University of Rochester)
  • U10CA037420 (Subvention/contrat des NIH des États-Unis)
  • NCI-2013-02237 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • URCC-12107 (Autre identifiant: DCP)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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