Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02189278
First received: July 10, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted

July 10, 2014
July 10, 2014
October 2013
June 2016   (final data collection date for primary outcome measure)
Surveillance adherence [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Same as current
No Changes Posted
  • Gynecologic exam adherence [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
  • Breast self-exam adherence [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Frequency of conducting breast self-exams assessed via patient report.
Same as current
  • Perceived benefits of surveillance [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Patient reported perceived benefits of breast cancer surveillance
  • Perceived barriers to breast cancer surveillance [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Patient reported perceived barriers to completing recommended breast cancer surveillance
Same as current
 
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
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.
  • Experimental: 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: Behavioral: Psychosocial Intervention
  • No Intervention: Treatment as usual
    Treatment as usual control.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
106
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02189278
Pro00022895, 5K07CA138767
Yes
Duke University
Duke University
National Cancer Institute (NCI)
Principal Investigator: Rebecca A Shelby, PhD Duke University
Duke University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP