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An Educational Intervention for Patients With Bladder Cancer

3 de agosto de 2017 actualizado por: Icahn School of Medicine at Mount Sinai

An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society

The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer.

Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.

Descripción general del estudio

Descripción detallada

The goals of the study are: 1) to further enhance the design and application of the ETE intervention, and 2) to provide data on the efficacy of the refined ETE intervention in a randomized-controlled study (RCT). To achieve these 2 goals, the study is divided in to 2 phases.

PHASE 1: To enhance and refine the design and application of the preliminary ETE intervention:

Aim 1-a: To explore knowledge, beliefs, values and expectations about treatment options, treatment decision making, and quality of life (QOL) among patients with BL Ca.

To achieve Aim 1-a of Phase 1, as a first step, 2 focus groups (FG; N = 10 each) of invasive BL Ca patients will be conducted to a) examine knowledge, beliefs, values, expectations, and affective responses about treatment options and treatment decision making, b) record difficulties and problems in post-surgical health care (e.g., using stoma appliances and catheters), and c) explore concerns patients have as they live with the impact of treatment. The ETE intervention will be refined based on FG results.

Aim 1-b: To explore patients' acceptability of the refined ETE intervention. To achieve Aim 1-b of Phase 1, additional 2 FG (FG; N = 10 each) of BL Ca survivors will be conducted to solicit input about the design and acceptability of the refined ETE intervention.

PHASE 2: Aim 2. To assess the efficacy of the ETE intervention in small RCT To achieve Aim 2 of Phase 2, a two-group RCT (standard care (SC) plus time and attention control condition, N = 62 patients; SC plus ETE intervention N = 62 patients) will be conducted to examine the efficacy of the ETE intervention. Phase 2 will provide a) a test of the efficacy of the refined ETE intervention for reducing decisional conflict and regret, and improving QOL and post-treatment stoma and pouch care controlling for potential clinical and socio-demographic covariates (e.g., treatment type, age).

Tipo de estudio

Intervencionista

Inscripción (Actual)

43

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

    • New York
      • New York, New York, Estados Unidos, 10029
        • Icahn School of Medicine at Mount Sinai
      • The Bronx, New York, Estados Unidos, 10468
        • James J. Peters VA Medical Center

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 a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Phase 1 (Focus groups/ In-depth Interview)

Inclusion Criteria:

  • treatment of invasive Bladder Cancer a with cystectomy and one of the three major urinary diversion methods
  • English speaking
  • between the ages of 18 and 85
  • able and willing to provide informed consent
  • may have received neoadjuvant or adjuvant chemotherapy, radiation therapy, and immunotherapy (BCG)

Exclusion Criteria:

  • metastatic disease or cancer recurrence
  • presence of other primary cancers
  • no access to a telephone

Phase 2 (randomized-controlled-study)

Additional Exclusion Criteria:

- treatment decision is made and /beginning/completion of treatment.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Education Intervention
In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.
1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.
Comparador de placebos: Nutrition Intervention
In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Decisional Regret Scale
Periodo de tiempo: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
Periodo de tiempo: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
Periodo de tiempo: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
Periodo de tiempo: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Self-Efficacy Scale
Periodo de tiempo: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Self-Efficacy Scale
Periodo de tiempo: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Self-Efficacy Scale
Periodo de tiempo: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Self-Efficacy Scale
Periodo de tiempo: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Treatment-related Values
Periodo de tiempo: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Treatment-related Values
Periodo de tiempo: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Treatment-related Values
Periodo de tiempo: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Treatment-related Values
Periodo de tiempo: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Regret Scale
Periodo de tiempo: Baseline

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

Baseline
Decisional Regret Scale
Periodo de tiempo: 1 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

1 month follow up
Decisional Regret Scale
Periodo de tiempo: 3 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

3 month follow up
Decisional Regret Scale
Periodo de tiempo: 6 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

6 month follow up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
quality of life
Periodo de tiempo: Baseline
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Baseline
quality of life
Periodo de tiempo: 1 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
1 month follow up
quality of life
Periodo de tiempo: 3 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
3 month follow up
quality of life
Periodo de tiempo: 6 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
6 month follow up
post-surgical self-care
Periodo de tiempo: Baseline
FACT-BL Ca additional concern
Baseline
post-surgical self-care
Periodo de tiempo: 1 month follow up
FACT-BL Ca additional concern
1 month follow up
post-surgical self-care
Periodo de tiempo: 3 month follow up
FACT-BL Ca additional concern
3 month follow up
post-surgical self-care
Periodo de tiempo: 6 month follow up
FACT-BL Ca additional concern
6 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Periodo de tiempo: Baseline
Baseline
CES-D scale Illness Perception Questionnaire (IPQ)
Periodo de tiempo: 1 month follow up
1 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Periodo de tiempo: 3 month follow up
3 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Periodo de tiempo: 6 month follow up
6 month follow up
Cancer worries scale
Periodo de tiempo: Baseline
Baseline
Cancer worries scale
Periodo de tiempo: 1 month follow up
1 month follow up
Cancer worries scale
Periodo de tiempo: 3 month follow up
3 month follow up
Cancer worries scale
Periodo de tiempo: 6 month follow up
6 month follow up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nihal E Mohamed, PhD, Icahn School of Medicine at Mount Sinai

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

1 de septiembre de 2013

Finalización primaria (Actual)

30 de junio de 2017

Finalización del estudio (Actual)

30 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2013

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2013

Publicado por primera vez (Estimar)

2 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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