- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01857882
Decision Support Workshop for Breast Reconstruction (DSW)
Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2C4
- Toronto General Hospital
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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:
- Patient age: 18 - 79 years at the time of consultation
- In situ or invasive biopsy confirmed breast adenocarcinoma
- Considered for immediate or delayed breast reconstruction
- First consultation for breast reconstruction
Exclusion Criteria:
- Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
- Completion any phase of reconstruction, or for revision reconstruction
- Patient cannot read or write in English.
- Cognitive impairment or uncontrolled psychiatric diagnosis
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: Decision Support Workshop
The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
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Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
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Sin intervención: Standard Care
Routine pre-consultation education
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Decision Self-efficacy Scale
Periodo de tiempo: Change from baseline decision self-efficacy at 1 week after surgical consultation
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Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation. |
Change from baseline decision self-efficacy at 1 week after surgical consultation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Decision Conflict Scale
Periodo de tiempo: Change from baseline decision conflict at 1 week after surgical consultation
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Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change.
The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).
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Change from baseline decision conflict at 1 week after surgical consultation
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Decision Preference and Decision Choice
Periodo de tiempo: baseline
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Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients.
It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.
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baseline
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Patient Involvement in Care Scale (PICS)
Periodo de tiempo: T1 (1 week after surgical consultation)
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PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.
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T1 (1 week after surgical consultation)
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Satisfaction With Information (Sub-scale of BREAST-Q)
Periodo de tiempo: T1 (1 week after surgical consultation)
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The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction.
The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team.
There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction.
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T1 (1 week after surgical consultation)
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Qualitative Interview Assessment
Periodo de tiempo: Within three months after initial consultation
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A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview.
Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability.
Telephone interviews will be conducted by a social worker trained in qualitative methods.
All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.
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Within three months after initial consultation
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Uptake Rate of Breast Reconstruction-Service Outcome
Periodo de tiempo: Six months after initial consultation
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The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
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Six months after initial consultation
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Length of Consultation-service Outcome
Periodo de tiempo: Duration of initial consultation
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The length of the initial consultation with the plastic surgeon, measured in minutes.
Consultations are expected to be between 20-60 mins.
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Duration of initial consultation
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Number of Consultations-service Outcomes
Periodo de tiempo: Six months after initial consultation
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The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded.
Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.
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Six months after initial consultation
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Breast Reconstruction Knowledge Test
Periodo de tiempo: Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.
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Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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Medical Outcomes Study Social Support Survey
Periodo de tiempo: baseline
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Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions).
Responses range from 1 (none of the time) to 5 (all the time).
The items in each domain were summed and then transformed to yield scores ranging from 0 to 100.
Higher scores indicate more support.
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baseline
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recruitment Rate-feasibility Outcome
Periodo de tiempo: Duration of recruiting, expected on average two months
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As this is a pilot study, the feasibility of conducting the study is highly important.
The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.
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Duration of recruiting, expected on average two months
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Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome
Periodo de tiempo: Duration of treatment-8 hours on day of treatment
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The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded.
This will be recorded directly after each day the treatment is delivered.
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Duration of treatment-8 hours on day of treatment
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Completion of Primary Outcome Measure-feasibility Outcome
Periodo de tiempo: 1 week after initial consultation
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Patients are to complete the primary outcome one week after initial consultation.
However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.
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1 week after initial consultation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Toni Zhong, MD, MHS, University Health Network, Toronto
Publicaciones y enlaces útiles
Publicaciones Generales
- Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.
- Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.
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 (Estimar)
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
Otros números de identificación del estudio
- 11-1027-CE
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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