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OpenTrials
Completed

NCT Number: NCT02189278

Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Surveillance adherence

    Time frame: 15 month follow-up

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

Secondary outcomes

  1. Gynecologic exam adherence

    Time frame: 15 month follow-up

    Receipt of recommended gynecologic exams (coded 0=no, 1=yes)

  2. Breast self-exam adherence

    Time frame: 6 month follow-up

    Frequency of conducting breast self-exams assessed via patient report.

Other outcomes

  1. Perceived benefits of surveillance

    Time frame: 6 month follow-up

    Patient reported perceived benefits of breast cancer surveillance

  2. Perceived barriers to breast cancer surveillance

    Time frame: 6 month follow-up

    Patient reported perceived barriers to completing recommended breast cancer surveillance

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2014
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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