Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

NCT02189278 | Completed DMC

• 2 other identifiers: Pro000228955K07CA138767
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Surveillance; Mammography; Adherence

Outcome Measures

Primary Outcomes (1)

• Surveillance adherence

  Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)

  15 month follow-up

Secondary Outcomes (2)

• Gynecologic exam adherence

  15 month follow-up

• Breast self-exam adherence

  6 month follow-up

Other Outcomes (2)

• Perceived benefits of surveillance

  6 month follow-up

• Perceived barriers to breast cancer surveillance

  6 month follow-up

Study Arms (2)

Psychosocial Intervention

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

Treatment as usual control.

Interventions

Psychosocial Intervention BEHAVIORAL

Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.

Psychosocial Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 21 years of age
• Unable to provide meaningful consent
• Surgically treated with bilateral mastectomy

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rebecca A Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: October 1, 2013
• Primary Completion: June 12, 2017
• Study Completion: June 12, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-09

Locations

US (1)