Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

October 2, 2018 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surveillance adherence
Time Frame: 15 month follow-up
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
15 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gynecologic exam adherence
Time Frame: 15 month follow-up
Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
15 month follow-up
Breast self-exam adherence
Time Frame: 6 month follow-up
Frequency of conducting breast self-exams assessed via patient report.
6 month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived benefits of surveillance
Time Frame: 6 month follow-up
Patient reported perceived benefits of breast cancer surveillance
6 month follow-up
Perceived barriers to breast cancer surveillance
Time Frame: 6 month follow-up
Patient reported perceived barriers to completing recommended breast cancer surveillance
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 12, 2017

Study Completion (Actual)

June 12, 2017

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022895
  • 5K07CA138767 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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