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Improving Surgical Decision-making in Young Women With Breast Cancer

26 de junio de 2020 actualizado por: Shoshana M. Rosenberg, Dana-Farber Cancer Institute

The overall goal of this study is to qualitatively assess the surgical decision-making process from both the patient and physician perspective

  1. Conduct short in-person interviews with young women prior to surgery
  2. Conduct focus groups with breast cancer survivors about their surgical decision and experience
  3. Interview surgical oncologists, plastic surgeons, medical and radiation oncologists about their experiences and how they communicate with breast cancer patients about local therapy decisions
  4. To survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Breast cancer in young women: Breast cancer is the most common cancer diagnosed in women younger than age 40 in the United States, with approximately 14,000 new cases each year. Young women face unique psychosocial challenges, most notably fertility, sexuality, and image concerns and are at a life stage where education, career, and family are important priorities. Concern about these issues may contribute to the greater psychosocial distress seen in younger women at both diagnosis and in follow-up compared with older women. Importantly, these concerns may also influence treatment decisions including receipt of chemotherapy, adherence to endocrine therapy, and surgical decisions. Thus, attending to the unique issues of young women may enhance not only quality of care and quality of life (QOL) but also potentially disease outcomes.

Surgical management of breast cancer: Standard loco-regional management of breast cancer entails partial mastectomy (i.e., breast conserving surgery) followed by radiation or mastectomy with or without radiation. The decision depends on a number of factors including extent of disease, family history, BRCA mutation status, and personal preference. In recent years, an increasing number of women have elected to undergo contralateral prophylactic mastectomy (CPM) in conjunction with surgery of the affected breast (usually choosing bilateral mastectomy), despite a lack of clear evidence for survival benefit from this procedure in the vast majority of women. In weighing the benefits and risks of CPM, one must consider the absolute risk reduction of a new primary breast cancer (usually relatively modest in the average risk survivor), the long and short-term risks of this additional surgery including potential complications (bilateral mastectomy is associated with a greater risk of surgical complications) and the impact on QOL. At the same time, one must consider the competing risk of systemic recurrence of a woman's initial breast cancer. Young women, in particular, have the greatest risk of systemic recurrence and death from their original cancer, lowering the likelihood of benefit of CPM in preventing a new primary breast cancer. However, while CPM rates have increased among all breast cancer patients, increased rates of CPM are particularly pronounced among the youngest women with breast cancer, with several studies identifying young age at diagnosis as one of the strongest determinants of CPM.Physicians and researchers have been observing and discussing this trend for a number of years and yet little has been done to intervene.

The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision. Based on these findings, the investigators will determine how to best improve the quality of the process, e.g., by correcting misperceptions, setting realistic expectations regarding the impact of surgery (including reconstruction) on QOL, improving communication with health care providers, and better management of anxiety surrounding diagnosis. This qualitative research is designed to build on prior quantitative analyses, by gaining an in depth perspective through focus groups and interviews, about certain issues identified as impacting the surgical decision process, including anxiety, fear of recurrence, and patient-physician communication.

Collectively, results from the qualitative assessment will inform a future phase of this research involving the design and subsequent development of a decision aid to help women make informed decisions about their breast cancer surgery.

The goal of this second phase of the research is to survey women about surgical decision-making prior to and after their consult in conjunction with pilot testing of a web-based decision aid to support high quality surgical decision-making in newly diagnosed young women with breast cancer.

Tipo de estudio

De observación

Inscripción (Actual)

145

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

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Young Women with a history of breast cancer and providers who care for them.

Descripción

Inclusion Criteria:

Patients for key informant interviews-

  1. Newly diagnosed women with Stage 0-3 breast cancer
  2. Between the ages of 18 and 40 who are seen at DFCI and have not yet had their primary breast cancer surgery.

Patients for focus groups:

  1. diagnosis of Stage 0-3 breast cancer at age 40 and younger
  2. currently between the ages of 18-43
  3. English-speaking
  4. 1-3 years from diagnosis
  5. Had breast cancer surgery
  6. no evidence of recurrent or metastatic disease.

Providers:

Must care for women who have breast cancer. Can be surgeons, surgical oncologists, medical and/or radiation oncologists

Patients for Surgical Decision Making Pilot

  1. Women with newly-diagnosed, unilateral Stage 0-3 breast cancer
  2. Between the ages of 18 and 40
  3. Who are seen by a surgeon at DFCI/BWH or Faulkner Hospital
  4. English speaking
  5. Have not yet had their primary breast cancer surgery

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

  • Modelos observacionales: Otro
  • Perspectivas temporales: Otro

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Key Informant interviews
20 in-person or phone qualitative interviews with patients.
qualitative data collection
Focus Groups
four qualitative focus groups of 6-10 women each.
qualitative data collection
Physician Interviews
physician qualitative interviews over the telephone.
qualitative data collection
Usual care cohort (pilot)
50 women who will be surveyed before and after their surgical consult
survey pre and post-surgical consult
Decision aid cohort (pilot)
50 women who will be surveyed before and after their surgical consult and will also be sent a web-based decision aid
survey pre and post-surgical consult
web-based decision aid post-surgical consult

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Thematic summary from the data gathered from the use of a moderator guide (series of probing questions) that inquires about the experiences surrounding the surgical decision-making process from both the patient and physician perspective
Periodo de tiempo: 1 year
The goal of the proposed research is to better understand and improve the surgical decision process in young women with breast cancer. Using qualitative research methods, we will comprehensively assess patient experiences - both patients who have had CPM and patients who did not - as well as physician perspectives regarding this decision.
1 year
Breast cancer knowledge
Periodo de tiempo: 2 weeks
Knowledge will be assessed using selected questions from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), an instrument designed to evaluate the quality of breast cancer treatment decisions as well as additional true/false questions related to side effects of radiation.
2 weeks
Decisional conflict
Periodo de tiempo: 2 weeks
Decisional conflict will be measured with the SURE scale. The SURE scale is composed of four items from the Decisional Conflict Scale that measure patients' uncertainty about which treatment choice and factors contributing to uncertainty.
2 weeks
Anxiety
Periodo de tiempo: 2 weeks
Anxiety will be assessed using the PROMIS Emotional Distress - Anxiety - Short Form.
2 weeks
Treatment goals and preferences
Periodo de tiempo: 2 weeks
have been adapted from the BCS-DQI. We will ask women to mark on a scale (not important - very important) the importance of several reasons in relation to their decision about surgery as well as concerns (not all concerned-very concerned) about local therapy.
2 weeks
Perception of decision process
Periodo de tiempo: 2 weeks
Perception of the decision process will be assessed with an adapted version of the Control Preferences Scale.
2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Usability of decision aid (DA)
Periodo de tiempo: 2 weeks-1 month
Assessment of what patients did and did not like about the DA, ways they think the DA can be improved, and how they felt the DA affected communication with their physician.
2 weeks-1 month

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Shoshana Rosenberg, ScD, Dana-Farber Cancer Institute

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

19 de febrero de 2016

Finalización primaria (Actual)

10 de abril de 2020

Finalización del estudio (Actual)

10 de abril de 2020

Fechas de registro del estudio

Enviado por primera vez

20 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

29 de diciembre de 2015

Publicado por primera vez (Estimar)

31 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2020

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

26 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 15-288
  • 1K01HS023680-01A1 (Subvención/Contrato de la AHRQ de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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