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Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02189278
Enrollment
100
Registered
2014-07-14
Start date
2013-10-31
Completion date
2017-06-12
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Surveillance, Mammography, Adherence

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.

Interventions

BEHAVIORALPsychosocial 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Surveillance adherence15 month follow-upReceipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)

Secondary

MeasureTime frameDescription
Gynecologic exam adherence15 month follow-upReceipt of recommended gynecologic exams (coded 0=no, 1=yes)
Breast self-exam adherence6 month follow-upFrequency of conducting breast self-exams assessed via patient report.

Other

MeasureTime frameDescription
Perceived benefits of surveillance6 month follow-upPatient reported perceived benefits of breast cancer surveillance
Perceived barriers to breast cancer surveillance6 month follow-upPatient reported perceived barriers to completing recommended breast cancer surveillance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026