Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Surveillance adherence
Study Overview
Brief Summary
Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. The early detection of recurrent and new cancers can best be achieved through the combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55% of breast cancer survivors do not undergo these procedures as recommended. This study tests a telephone-based psychosocial intervention aimed at improving adherence to recommended surveillance in breast cancer survivors. The psychosocial intervention for improving adherence is compared to treatment as usual.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •21 years of age or older
- •Diagnosis of Stage I to IIIA breast cancer
- •Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
- •No diagnosis of recurrent breast cancer or a new primary cancer
- •Able to provide meaningful consent
Exclusion Criteria
- •< 21 years of age
- •Unable to provide meaningful consent
- •Surgically treated with bilateral mastectomy
Arms & Interventions
Psychosocial Intervention
Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
Intervention: Psychosocial Intervention (Behavioral)
Treatment as usual
Treatment as usual control.
Outcomes
Primary Outcomes
Surveillance adherence
Time Frame: 15 month follow-up
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Secondary Outcomes
- Gynecologic exam adherence(15 month follow-up)
- Breast self-exam adherence(6 month follow-up)