Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Psychosocial Intervention

• Registration Number: NCT02189278
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2017-06-12
• Study Completion: 2017-06-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial Intervention	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.

Primary Outcome Measures

Name	Time	Method
Surveillance adherence	15 month follow-up	Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)

Secondary Outcome Measures

Name	Time	Method
Gynecologic exam adherence	15 month follow-up	Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
Breast self-exam adherence	6 month follow-up	Frequency of conducting breast self-exams assessed via patient report.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States