Breast Cancer Survivorship Clinical Trials

Trials Currently Open

Focus Group for Patients with Metastatic Breast Cancer
The Breast Cancer Survivorship Center is actively recruiting metastatic breast cancer patients to participate in a single 90-minute focus group. Susan Krigel, PhD, is conducting this focus group to learn more about the needs of patients with metastatic breast cancer.

Benefits include:
Participating in research designed to identify ways health care professionals can better meet the physical and emotional needs of patients.

Eligibility Criteria:

• Age 18 or older
• Female diagnosed with metastatic breast cancer
• Able to speak, read and write English

Focus group participation includes:

• Attending a one 90-minute focus group
• Completing a questionnaire about treatment history

Breast Cancer Risk Biomarkers and Energy Balance in Post-Menopausal Breast Cancer Survivors
Funded by Back in the Swing and an NIH BIRCWH K12 Award.
This is a weight control research program designed to teach participants how to incorporate a healthy diet and regular physical activities into their daily lives. The program is for women who are overweight post-diagnosis, have completed initial breast cancer treatment and are interested in losing weight. We will also be investigating the impact of structured exercise on heart function. This includes resistance training and cardiovascular exercise. We will use cardio-pulmonary fitness testing. For those interested, we will collect a small sample of muscle from the thigh and evaluate changes on the cellular level.

Participants will meet twice weekly for the first four weeks to learn safe and effective methods for resistance training. For the following 24 weeks, participants will meet once a week to discuss balanced nutrition, the importance of regular physical activities and techniques to help change unwanted behaviors. These meetings will alternately be held by phone, in person and in a group setting. The program allows participants the flexibility to choose from a variety of prepackaged meals for lunch and dinner, along with low-calorie shakes and five daily servings of fruits and vegetables.

By the end of the program participants are expected to lose at least 5-10% of their body weight and will be able to exercise for one hour, five days per week.

Axillary Reverse Mapping (ARM)
Each year in the United States, a large number of women undergo the surgical removal of axillary lymph nodes. This operation is generally performed on all women with operable breast cancer in whom adjuvant therapy will be considered if the lymph nodes are positive for metastatic cancer cells. The Axillary Reverse Mapping (ARM) study is designed to expand our knowledge and techniques involving lymph node surgery.

Lymphedema and psychological distress are often reported as problems for patients who have had axillary lymph node resections. This study investigates a new procedure that could minimize side effects resulting from lymph node removal. During the study, patients will undergo seven arm assessments. No special appointments will be needed for this monitoring. It is done during standard follow-up visits.

Eligibility Criteria:

• Age 18 or older
• Patient currently seen at The University of Kansas Cancer Center for lymph node evaluation for breast cancer or in association with prophylactic mastectomy
• Not pregnant or breastfeeding
• Patient has undergone excisional or needle biopsy indicating diagnosis of in-situ or invasive breast cancer

Surgery will require lymph node sampling

Exclusions to patient eligibility:

• Patients cannot have undergone final surgery that includes previous removal of the breast or lymph nodes
• Blue dye allergy

Clinical trials currently closed

Please check back later for further opportunities.

Cardiopulmonary Testing and Correlates of Breast and Cardiac Risk Markers in Breast Cancer Survivors
This study was conducted to help screen for asymptomatic cardiac dysfunction and to provide information on cardiopulmonary fitness leading to a recommendation for post-treatment rehabilitation. Asymptomatic cardiac dysfunction is associated with short- and long-term effects of cancer treatment, and cardiac events are the leading cause of death in long-term survivors next to recurrence of primary malignancy.

Eligibility Criteria:

• Previously diagnosed with stage I-IIIa breast cancer and treatment with chemotherapy and/or radiation therapy
• Age 30 to 60
• No evidence of metastatic disease
• At least three months from completing initial chemotherapy and/or radiation therapy and within 10 years of initial diagnosis
• Two of the cardiac risk factors: overweight/obese, hypertension, elevated LDL, positive family history, sedentary lifestyle, smoker, metabolic syndrome
• One treatment-related risk factor: chemotherapy and/or left breast radiation

Chemotherapy-Related Cognitive Impairment: The Breast Cancer Experience
This study included breast cancer patients who received chemotherapy and reported changes in thinking or memory (cognitive function).

Those who participated were asked to complete a questionnaire, take part in an interview with the researcher and participate in a small-group interview with others who took part in the study.

Eligibility Criteria:

• Women age 18 or older
• Diagnosed with any stage breast cancer
• Within six to 12 months of completing standard-dose chemotherapy
• Previous or current hormonal therapy is acceptable
• Self-reported changes in cognitive function (such as changes in ability to concentrate, remember or focus on tasks; difficulty with finding the right words or phrases or doing mathematical calculations; or problems with sense of direction when driving)
• Able to read, write, speak and understand English

Eligibility Exclusions:

• Evidence of central nervous system metastases
• History of mental illness, dementia or Alzheimer's disease
• Currently taking psychotropic medications (with the exception of benzodiazepines or selective serotonin reuptake inhibitors prescribed for the treatment of anxiety or depression)

Positive Steps
Funded by KU Cancer Center Internal Pilot Award
One of the most challenging aspects of a cancer diagnosis is managing employment changes. Positive Steps was a pilot research study designed to help women manage cancer-related job challenges and improve quality of life through exercise. Participants signed up within six weeks of beginning treatment and received eight personalized sessions by telephone. They were also given education materials, a pedometer and generous gift cards. Participants were asked to document exercise and fill out questionnaires and complete phone sessions with the research staff.

Eligibility Criteria:

• Endometrial (uterine) or breast cancer
• Cancer at only one site (i.e. no simultaneous primary cancer elsewhere)
• No known distant metastases
• Newly diagnosed, defined as less than six weeks after beginning primary treatment (primary treatment defined as definitive surgery and/or systemic anti-cancer drug treatment, either hormonal or chemotherapeutic, and/or radiation)
• Age 35 to 57
• Employed full time (i.e., working for pay more than 35 hours per week) by an external organization (i.e., not self-employed) at the time of cancer presentation
• Treating physician has approved unrestricted participation in physical activity up to moderate intensity
• Baseline questionnaire completed by six weeks after initiating primary treatment

Exploring How Women Make Treatment Decisions After a Breast Cancer Diagnosis
As part of her doctoral dissertation research, Cheryl Spittler, RN, MSN, CEN, CPSN, is interested in learning how women diagnosed with breast cancer have made decisions about their treatment options. She hopes to provide health care providers with information to help women make informed and satisfied decisions after receiving a breast cancer diagnosis.

This survey asked participants about information needs after a breast cancer diagnosis, how decisions about treatment options are made, and what personal responses occurred after those decisions were made.

Eligibility criteria:

• Breast cancer survivors who completed treatment and/or surgical procedures for at least three months and less than five years
• Age 18 or older
• Access to a computer and able to perform simple computer functions and complete five online questionnaires
• Able to read, write and speak English
• Also eligible – women on hormonal therapy, such as tamoxifen (Novaldex), raloxifene (Evista), anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara)

Participation in the study included:

• Completing a participant information form on the computer (five minutes)
• Completing five decision questionnaires on the computer (25 minutes)
• Possibly being selected to participate in a focus group at the Breast Cancer Survivorship Center (90-120 minutes)