Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Duke University

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Psychosocial Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02189278

5K07CA138767 (U.S. NIH Grant/Contract)

Pro00022895

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Psychosocial Intervention

Experimental group

Description:

Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.

Treatment:

Behavioral: Psychosocial Intervention

Treatment as usual

No Intervention group

Description:

Treatment as usual control.