Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189278
• Other study ID #: Pro00022895
• Secondary ID: 5K07CA138767
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 12, 2017

Study information

• Verified date: September 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived benefits of surveillance	Patient reported perceived benefits of breast cancer surveillance	6 month follow-up
Other	Perceived barriers to breast cancer surveillance	Patient reported perceived barriers to completing recommended breast cancer surveillance	6 month follow-up
Primary	Surveillance adherence	Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)	15 month follow-up
Secondary	Gynecologic exam adherence	Receipt of recommended gynecologic exams (coded 0=no, 1=yes)	15 month follow-up
Secondary	Breast self-exam adherence	Frequency of conducting breast self-exams assessed via patient report.	6 month follow-up