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Activo, sin reclutamientoNCT02263014Registro de ClinicalTrials.gov

Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

Breast Cancer

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
345 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. Researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions.

Leer la descripción completa

With your verbal permission, you may have been asked to complete a questionnaire about your surgical treatment preferences for breast cancer as part of initial screening for this study. This takes about 5 minutes to complete.

If you agree to participate in this study, during the same visit you will complete a questionnaire about your background, such as your education level, marital status, and family history of cancer. This should take about 3 minutes to complete.

You will also be asked to complete a questionnaire about your surgery decisions and your feelings about those decisions at the following times: around the time you enroll in study before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This questionnaire should take about 30-40 minutes to complete each time. You may complete this questionnaire at the clinic or you may complete it at home. If you chose to complete the questionnaire at home, you will be given a postage-paid envelope to mail it back to the study staff.

Length of Study:

After you complete all of the questionnaires, your participation in this study will be over.

This is an investigational study.

A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at MD Anderson and up to 100 will take part at Kelsey-Seybold.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

1. Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
2. Age 18 or older
3. Able to speak, read, and write English.
4. Spouse/Partner: Married or living with patient for a year or more
5. Spouse/Partner: Age 18 or older
6. Spouse/Partner: Able to speak, read, and write English

Exclusion Criteria:

1. Patients with previous breast cancer
2. Prior history of prophylactic mastectomy
3. Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Población del estudio

Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Contralateral Prophylactic Mastectomy (CPM) Group

Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.

Behavioral: Questionnaires

No Contralateral Prophylactic Mastectomy (CPM) Group

Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.

Behavioral: Questionnaires

Questionnaires BEHAVIORAL

Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score

Plazo: Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.

Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.

Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision

Plazo: One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.

The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.

Hay resultados publicados en el registro.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Kelsey-SeyboldHouston, Texas, United StatesEstado desconocido
University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
M.D. Anderson Cancer Center
Inicio del estudio
24 feb 2014 Real
Finalización primaria
1 oct 2016 Real
Finalización del estudio
30 abr 2028 Estimado
Primera publicación
13 oct 2014 Estimado
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Treatment Decisions and Breast Cancer: Psychosocial Outcomes

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.

No incluyas expedientes médicos, diagnósticos, medicamentos, números de seguro ni otros datos sensibles. Este formulario es para preguntas generales, no para atención urgente.

Enviar una pregunta no te inscribe en un estudio.

Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026