Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
25 de enero de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
418
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92182
- San Diego State University
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Hawaii MU-NCORP
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Illinois
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Decatur, Illinois, Estados Unidos, 62526
- Heartland NCORP
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Kansas
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Prairie Village, Kansas, Estados Unidos, 66208
- Kansas City Clinical Oncology Program
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Gulf South MU-NCORP
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55426
- Metro MN NCORP
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Nevada Cancer Research Foundation NCORP
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Las Vegas, Nevada, Estados Unidos, 89106
- Nevada NCORP
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New York
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Rochester, New York, Estados Unidos, 14642
- URCC / University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus, Ohio, Estados Unidos, 43215
- Columbus NCORP
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Dayton, Ohio, Estados Unidos, 45420
- Dayton Community Oncology Program
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822
- Geisinger Cancer Institute NCORP
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Greenville Health System Cancer Instutite/Greenville NCORP
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- Wisconsin NCORP
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Aurora NCORP
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
print educational intervention
Otros nombres:
|
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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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
Periodo de tiempo: Day 3 to 7
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Decision Regret Scale (DRS)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Jacobsen, University of Rochester
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2014
Finalización primaria (Actual)
31 de agosto de 2016
Finalización del estudio (Actual)
1 de noviembre de 2016
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2014
Primero enviado que cumplió con los criterios de control de calidad
31 de enero de 2014
Publicado por primera vez (Estimar)
4 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
25 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- URCC12107 (Otro identificador: University of Rochester)
- U10CA037420 (Subvención/contrato del NIH de EE. UU.)
- NCI-2013-02237 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- URCC-12107 (Otro identificador: DCP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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