- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07936682
PreCharge: An Innovative Digital Program to Increase Coping, Resilience, and Health Care Engagement Among Cancer Previvors ((PreCharge))
The goal of this clinical trial is to learn if PreCharge helps adults cope with an inherited risk of cancer. PreCharge is a personalized online support program for people with a hereditary cancer syndrome. The study is for adults who have not had cancer, with an exception for non-melanoma skin cancer.
The main question the study aims to answer is:
• Does PreCharge help participants feel more confident in their ability to cope with their inherited cancer risk? Researchers will compare participants who use PreCharge with participants who do not use the program during the study. Researchers will also look at participants' resilience, anxiety, depressive symptoms, cancer worry, and overall well-being.
Participants will be assigned by chance to one of two groups. Participants in both groups will answer online surveys at the start of the study and about 3 and 6 months later.
- Participants in the PreCharge group will have access to the program for 6 months. They will receive text messages and can use the online program's information and activities.
- Participants in the comparison group will have access to a webpage with mental health and hereditary cancer resources.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kerry E Evers, Ph.D.
- Número de teléfono: 401-360-2985
- Correo electrónico: kevers@prochange.com
Copia de seguridad de contactos de estudio
- Nombre: Madison Gilmore
- Número de teléfono: 401-360-2988
- Correo electrónico: mgilmore@prochange.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 years or older.
- Reside in the United States.
- Self-report having a hereditary cancer syndrome.
- Able to read and communicate in English.
- Willing to receive text messages during the 6-month study period.
- Score of 100 or less on the 12-item Cancer Behavior Inventory-Brief Version (CBI-B) at screening.
Exclusion Criteria:
- Self-reported personal history of cancer, except non-melanoma skin cancer.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PreCharge
Participants receive access to PreCharge, a personalized digital psychosocial support program, for six months. The program includes a web-based portal and text messages that provide tailored information, activities, and support. Participants complete study assessments at baseline and at three and six months. |
PreCharge is a six-month, personalized digital psychosocial support program for adults with hereditary cancer syndromes who have not been diagnosed with cancer. The program is delivered through a web-based portal and tailored text messages. It provides tailored information, activities, and tools to support coping with hereditary cancer risk. Participants can access the portal throughout the intervention period, and their responses to check-ins help personalize program recommendations and messages over time. |
|
Sin intervención: Assessment-Only Control
Participants complete study assessments at baseline and at three and six months. They do not receive access to the PreCharge program during the study. They have access to a static webpage with mental health and hereditary cancer resources. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in coping self-efficacy
Periodo de tiempo: Screening (baseline), 3 months, and 6 months
|
Coping self-efficacy will be assessed using the 12-item Cancer Behavior Inventory-Brief Version (CBI-B), adapted for individuals with hereditary cancer risk who have not been diagnosed with cancer (previvors). Each item is rated from 1 (not at all confident) to 9 (totally confident). Item scores are summed to produce a total score ranging from 12 to 108, with higher scores indicating greater coping self-efficacy. Changes in total scores over time will be compared between the PreCharge and assessment-only control groups. The screening score serves as the baseline measure. |
Screening (baseline), 3 months, and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in depressive symptoms measured by the Patient Health Questionnaire-2 (PHQ-2)
Periodo de tiempo: Baseline, 3-month follow-up, and 6-month follow-up.
|
Depressive symptoms will be assessed using the two-item Patient Health Questionnaire-2 (PHQ-2). Participants report how often they experienced depressed mood and little interest or pleasure in activities during the previous two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 6, with higher scores indicating more frequent depressive symptoms. Changes over time will be compared between study groups. |
Baseline, 3-month follow-up, and 6-month follow-up.
|
|
Change in anxiety symptoms measured by the Generalized Anxiety Disorder-2 (GAD-2)
Periodo de tiempo: Baseline, 3-month follow-up, and 6-month follow-up.
|
Anxiety symptoms will be assessed using the two-item Generalized Anxiety Disorder-2 (GAD-2). Participants report how often they were bothered by feeling nervous, anxious, or on edge and being unable to stop or control worrying during the previous two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 6, with higher scores indicating more frequent anxiety symptoms. Changes over time will be compared between study groups. |
Baseline, 3-month follow-up, and 6-month follow-up.
|
|
Change in resilience measured by the Connor-Davidson Resilience Scale-10 (CD-RISC-10)
Periodo de tiempo: Baseline, 3-month follow-up, and 6-month follow-up.
|
Resilience will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10). Each item is scored from 0 (not at all true) to 4 (true nearly all the time). Item scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater resilience. Changes over time will be compared between study groups. |
Baseline, 3-month follow-up, and 6-month follow-up.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kerry E Evers, Ph.D., ProChange Behavior Solutions
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genéticas Congénitas
- Enfermedades metabólicas
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades del Colon
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Enfermedades de la piel
- Enfermedades de los senos
- Trastornos por deficiencia en la reparación del ADN
- Neoplasias de mama
- Neoplasias Ováricas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Neoplasias Colorrectales Hereditarias No Polipósicas
- Síndromes Neoplásicos Hereditarios
- Síndrome de cáncer de mama y de ovario hereditario
Otros números de identificación del estudio
- PreCharge 2025-01
- R44CA275673 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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