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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

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Surveillance, Mammography, Adherence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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

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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