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Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02189278
First received: July 10, 2014
Last updated: February 8, 2017
Last verified: January 2017

July 10, 2014
February 8, 2017
October 2013
June 2017   (Final data collection date for primary outcome measure)
Surveillance adherence [ Time Frame: 15 month follow-up ]
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Same as current
Complete list of historical versions of study NCT02189278 on ClinicalTrials.gov Archive Site
  • Gynecologic exam adherence [ Time Frame: 15 month follow-up ]
    Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
  • Breast self-exam adherence [ Time Frame: 6 month follow-up ]
    Frequency of conducting breast self-exams assessed via patient report.
Same as current
  • Perceived benefits of surveillance [ Time Frame: 6 month follow-up ]
    Patient reported perceived benefits of breast cancer surveillance
  • Perceived barriers to breast cancer surveillance [ Time Frame: 6 month follow-up ]
    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
Intervention Model: Parallel Assignment
Masking: No masking
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.
 
Active, not recruiting
100
June 2017
June 2017   (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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02189278
Pro00022895
5K07CA138767 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Not Provided
Not Provided
Duke University
Duke University
National Cancer Institute (NCI)
Principal Investigator: Rebecca A Shelby, PhD Duke University
Duke University
January 2017

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