Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Psychosocial Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Intervention<br>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<br>* Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.<br>|
| No Intervention: Treatment as usual<br>Treatment as usual control. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Surveillance, Mammography, Adherence