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Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy (PRISME)

29 de abril de 2020 actualizado por: Ipsen

Health Related Quality of Life and Multidimensional Evaluations of a Cohort of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy

The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.

Tipo de estudio

De observación

Inscripción (Actual)

831

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

  • Francia
      • Paris, Francia
        • Ipsen Central Contact

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra no probabilística

Población de estudio

Prostate Cancer subjects aged ≥ 60

Descripción

Inclusion Criteria:

  • Subject presenting with histologically confirmed prostate cancer
  • Subject of 60 years and older
  • Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study
  • Subject giving his written consent to participate in the study
  • Subject able to complete questionnaires

Exclusion Criteria:

  • Subject simultaneously participating in a clinical trial
  • Subject who previously received a hormonal therapy during the last 6 months before inclusion

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Prostate cancer subjects 60-<70 years
Otro: Data collection
Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.
Prostate cancer subjects 70-<75 years
Otro: Data collection
Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.
Prostate cancer subjects ≥ 75 years
Otro: Data collection
Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of Life (QOL) as evaluated by Quality of Life Questionnaire-Elderly 14 items (QLQ-ELD-14)
Periodo de tiempo: Change from baseline at 6 months
Evolution overall and in subgroups of age ([60-<70], [70- <75] and ≥ 75 years).
Change from baseline at 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HRQOL Visual Analog Scale (VAS) score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Health status scores as evaluated by G8 questionnaire
Periodo de tiempo: Baseline and 6 months
Baseline and 6 months
Overall condition VAS score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with their general health status by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Urinary function scores as evaluated by QOL question of the International Prostate Symptom Score (IPSS)
Periodo de tiempo: Baseline and 6 months
Subjects will be asked to indicate the score corresponding to their evaluation of their quality of life related to urinary symptoms in response to the following question 'If you were to live the rest of your life with this way of urinating, would you say you would be:' on a scale from 0 (very satisfied) to 6 (very upset).
Baseline and 6 months
Urinary function score VAS
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with their urinary function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Sexual function scores as evaluated by 3 questions on sexual domain of the Urolife Benign Prostatic Hyperplasia-Quality Of Life 9 (BPH-QoL 9) questionnaire
Periodo de tiempo: Baseline and 6 months
Baseline and 6 months
Sexual function VAS score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with their sexual function by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Cognitive status scores as evaluated by Mini Mental State (MMS)
Periodo de tiempo: Baseline and 6 months
Baseline and 6 months
Memory VAS score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with memory (your capacity to remind events or persons you meet) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Mood scores as evaluated by mini Geriatric Depression Scale (GDS) questionnaire
Periodo de tiempo: Baseline and 6 months
Subjects will be asked four questions and their responses 'Yes' or 'No' will be scored from 0 to 1.
Baseline and 6 months
Mood VAS score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with mood (your feeling of happiness, confidence and serenity) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months
Motricity scores as evaluated by G8 questionnaire specific domain (3rd item)
Periodo de tiempo: Baseline and 6 months
Mobility will be scored as follows 'Bed or chair bound' = 0, 'Able to get out of bed/chair but does not go out' = 1, 'Goes out' = 2
Baseline and 6 months
VAS motricity score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with motricity (your ability to move by yourself in your home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'
Baseline and 6 months
Autonomy question
Periodo de tiempo: Baseline and 6 months
Subjects respond either 'yes' or 'no' to the following autonomy question 'Is the patient living independently at home?'
Baseline and 6 months
Autonomy VAS score
Periodo de tiempo: Baseline and 6 months
Subjects evaluate level of satisfaction with autonomy (your ability to manage your life alone at home or outside) by indicating a position along a 10 cm-linear analog scale that ranges between 'Not satisfied at all' and 'Totally satisfied'.
Baseline and 6 months

Colaboradores e Investigadores

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

Patrocinador

Ipsen

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)

9 de marzo de 2018

Finalización primaria (Actual)

28 de febrero de 2020

Finalización del estudio (Actual)

28 de febrero de 2020

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2018

Publicado por primera vez (Actual)

4 de mayo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2020

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

29 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A-FR-52014-228

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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