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Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02189278
First Posted: July 14, 2014
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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.


Other Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: October 2013
Study Completion Date: June 12, 2017
Primary Completion Date: June 12, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189278


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rebecca A Shelby, PhD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02189278     History of Changes
Other Study ID Numbers: Pro00022895
5K07CA138767 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2014
First Posted: July 14, 2014
Last Update Posted: September 1, 2017
Last Verified: January 2017

Keywords provided by Duke University:
Breast Cancer
Surveillance
Mammography
Adherence

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