This study investigates how different treatment decisions influence the quality of life of women with breast cancer. Information learned from this study may be used by researchers to help patients with breast cancer be more informed when making decisions about surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02263014.
PRIMARY OBJECTIVES:
I. To prospectively examine the psychosocial outcomes of women with sporadic breast cancer who have contralateral prophylactic mastectomy (CPM; removal of the cancer-free breast) versus those who do not.
II. Determine the impact of patient and physician characteristics on the outcomes.
EXPLORATORY OBJECTIVE:
I. To interview a sample of spouses/partners of participants and physicians to obtain their perspective on the decision making process and thoughts and feelings about CPM.
OUTLINE:
Patients complete questionnaires about their surgery decisions and feelings about the decisions over 30-40 minutes each at baseline and 1, 6, 12, and 18 months following surgery. Patients may also participate in semi-structured interviews about their experience of having CPM (or not) at 12 and 18 months following surgery.
Spouses/partners of breast cancer patients may participate in a semi-structured interview about their perspectives on the decision making process and thoughts and feelings about CPM. Physicians who treat patients with breast cancer may also participate in a semi-structured interview about how they approach the decision making process with women considering CPM and their perceptions about women’s outcomes.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAbenaa Marcia Brewster
