- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01709344
Reducing Disability in Older Adult Cancer Survivors
A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors
Older adults who are treated for cancer are at risk of developing disabilities due to the symptoms of cancer and the side effects of treatment. Disability occurs when a person has trouble performing the activities he or she needs to do in everyday life. For example, fatigue and pain can make it difficult for an older adult to do housework, leisure, or volunteer activities. Disability makes it harder for older adults to stay active and be productive members of the community, and it can increase the costs of healthcare.
Current approaches to cancer rehabilitation focus on using exercise, education, and social support to reduce cancer treatment side effects. These are important strategies to reduce disability, yet some side effects persist despite best efforts to resolve them. To fully reduce disability, people often need to adapt their activities or the environments in which they are performed.
The goal of this study is to test an occupational therapy (OT) intervention that teaches activity planning skills to foster survivors' ability to adapt activities, routines, and environments in order to minimize disability. The project targets adults over the age of 65 who are experiencing disability during or after cancer treatment. The project has two stages. First, twelve older adult cancer survivors will individually participate in the community-based intervention. After they have completed the program the investigators will revise the intervention to emphasize what they found most effective and helpful, and to eliminate aspects of the intervention that are perceived as unhelpful or redundant. The research question for this first stage of the project is, "To what degree is it feasible for survivors to enroll in the study, complete the six-week intervention, and complete the three outcome assessments?" In the second stage of the project, the investigators will test the revised intervention, comparing it to conventional care. The research question for the second stage of the project is, "Do the people receiving the intervention have higher activity levels, greater behavioral activation, lower levels of disability, and better quality of life compared to those people who receive traditional cancer care?" The intervention is appropriate for people who have been diagnosed with any type of cancer. It is designed to focus on whatever activities are most important to each participant. The novelty of the proposed intervention lies in the combination of the OT strategies of activity and environmental adaptation with explicit training in activity planning to teach survivors to find creative ways to engage in valued activities (e.g., taking care of one's home and family members, and participating in leisure, community, social and work activities). If the intervention is effective in reducing disability, it will give us another tool to reduce the impact of cancer on the daily lives of cancer survivors.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
- Age 65 years or older.
- Experiencing disability as indicated by a score of > 3 on the Vulnerable Elders Survey or an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"
- Either: a. Diagnosed with any solid or hematological cancer, undergoing treatment for curative intent or within six months of completion of therapy with absence of disease recurrence; or b.Diagnosed with metastatic breast cancer or chronic hematologic malignancies with a life expectancy of > 2 years
Exclusion Criteria
- Moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool.
- Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: PS-OT
Problem-solving Occupational Therapy
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Otros nombres:
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Otro: Usual care
Access to all supportive and rehabilitative services available at DHMC
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Supportive and rehabilitation services available at DHMC
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Disability
Periodo de tiempo: Eight weeks
|
Late-Life Function and Disability Instrument
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Eight weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of Life
Periodo de tiempo: Eight weeks
|
Functional Assessment of Cancer Therapy
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Eight weeks
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Activity level
Periodo de tiempo: Eight weeks
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Activity Card Sort
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Eight weeks
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Behavioral activation
Periodo de tiempo: Eight weeks
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Behavioral activation scale
|
Eight weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depression
Periodo de tiempo: Eight weeks
|
Patient Health Questionnaire-9 (PHQ-9)
|
Eight weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Otros números de identificación del estudio
- D12110
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. .
Ensayos clínicos sobre Cáncer
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Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
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Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
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Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
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Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
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GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
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University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
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Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento
Ensayos clínicos sobre PS-OT
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The University of Texas Medical Branch, GalvestonUniversity of Texas Southwestern Medical Center; United States Army Institute... y otros colaboradoresTerminadoDebilidad muscular | Músculo; Fatiga, Corazón | Efecto tardío de la quemadura | Rehabilitación de quemadurasEstados Unidos
-
Seoul National University Bundang HospitalActivo, no reclutando
-
Virginia Commonwealth UniversityTerminadoCoordinación o Función Motora; Trastorno del desarrolloEstados Unidos
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Henry Ford Health SystemHenry Ford HospitalTerminadoImplante transcatéter de válvula aórticaEstados Unidos
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Oncotartis, Inc.DesconocidoLinfoma | Linfoma Folicular | Linfoma de células B | Linfoma No Hodgkin | Linfoma de células T | Linfoma de Hodgkin | Linfoma De Células T PeriféricoEstados Unidos
-
The Methodist Hospital Research InstituteAún no reclutando
-
Johns Hopkins UniversityInscripción por invitaciónDormir | Depresión ansiedad | La inactividad física | Hospitalización PsiquiátricaEstados Unidos
-
Loma Linda UniversityTerminadoDepresión | Estrés Psicológico | Ansiedad | Trastorno de estrés postraumáticoEstados Unidos
-
Taipei City HospitalTerminadoFracturas de cadera | Actividades de la vida diariaTaiwán
-
Ohio State UniversityLifeCare AllianceActivo, no reclutandoEnfermedades cardíacas | Diabetes mellitus | Caída Accidental | Dieta, Alimentación y NutriciónEstados Unidos