Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
psychosocial effects of cancer and its treatment, ductal breast carcinoma in situ, breast cancer in situ, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer. PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.
Detailed description
OBJECTIVES: * Compare the impact of rapid genetic counseling (RGC) vs usual care on the medical decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast cancer. * Compare the impact of these interventions on the quality of life and psychological well being of these patients. * Determine baseline factors that predict who is most and least likely to benefit from RGC in patients undergoing these interventions. * Compare the cost per quality adjusted life year saved from a societal perspective in patients undergoing these interventions. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site. Patients are randomized to 1 of 2 interventional arms. * Arm I (rapid genetic counseling): Patients undergo a 1½ hour genetic counseling session either in person or by telephone. Patients who undergo telephone counseling receive a booklet of visual aids and educational materials. Patient preferences and values are assessed immediately after counseling. Some patients may undergo BRCA1/2 status determination. Patients undergo follow-up telephone interviews at 1, 6, and 12 months. * Arm II (usual care): Patients receive a packet of breast cancer treatment educational materials. Patient preferences and values are assessed 2 weeks later. Patients undergo follow-up telephone interviews as in arm I. In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months. After completion of the study, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Interventions
BEHAVIORALcounseling intervention
OTHEReducational intervention
PROCEDUREpsychosocial assessment and care
Sponsors
National Cancer Institute (NCI)
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Newly diagnosed breast cancer, meeting 1 of the following criteria: * Stage 0 disease (ductal carcinoma in situ only) * Stage I-IIIA disease * Must meet 1 of the following criteria: * Diagnosis before 50 years of age * Diagnosis after 50 years of age AND has 1 of the following: * First or second degree relative diagnosed with breast cancer before 50 years of age * First or second degree relative diagnosed with ovarian cancer at any age * First or second degree relative diagnosed with male breast cancer at any age * Must not have initiated definitive treatment for breast cancer * No bilateral, metastatic, or inflammatory breast cancer * No prior BRCA1/2 counseling or testing * No prior diagnosis of metastatic cancer of any type * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Surgery * No prior bilateral mastectomy for breast cancer Other * No concurrent treatment for cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization | 1, 6, and 12 months |
| Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization | 1, 6, and 12 months |
| Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization | 1, 6, and 12 months |
| Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization | 1 month |
| Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization | 1 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization | 12 months |
Countries
United States
Outcome results
None listed