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
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Psychosocial Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 106
Study Start Date: October 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Treatment as usual
Treatment as usual control.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189278

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Rebecca A Shelby, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02189278     History of Changes
Other Study ID Numbers: Pro00022895, 5K07CA138767
Study First Received: July 10, 2014
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Breast Cancer
Surveillance
Mammography
Adherence

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014