Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Surveillance, Mammography, Adherence
Eligibility 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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychosocial Intervention
Treatment as usual
Arm Description
Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
Treatment as usual control.
Outcomes
Primary Outcome Measures
Surveillance adherence
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Secondary Outcome Measures
Gynecologic exam adherence
Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
Breast self-exam adherence
Frequency of conducting breast self-exams assessed via patient report.
Full Information
NCT ID
NCT02189278
First Posted
July 10, 2014
Last Updated
October 2, 2018
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02189278
Brief Title
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Official Title
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Surveillance, Mammography, Adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychosocial Intervention
Arm Type
Experimental
Arm Description
Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual control.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Intervention
Intervention Description
Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
Primary Outcome Measure Information:
Title
Surveillance adherence
Description
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Time Frame
15 month follow-up
Secondary Outcome Measure Information:
Title
Gynecologic exam adherence
Description
Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
Time Frame
15 month follow-up
Title
Breast self-exam adherence
Description
Frequency of conducting breast self-exams assessed via patient report.
Time Frame
6 month follow-up
Other Pre-specified Outcome Measures:
Title
Perceived benefits of surveillance
Description
Patient reported perceived benefits of breast cancer surveillance
Time Frame
6 month follow-up
Title
Perceived barriers to breast cancer surveillance
Description
Patient reported perceived barriers to completing recommended breast cancer surveillance
Time Frame
6 month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Shelby, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
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