Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

NCT ID: NCT02189278

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-06-12

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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Psychosocial Intervention

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

Group Type EXPERIMENTAL

Psychosocial Intervention

Intervention Type 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.

Treatment as usual

Treatment as usual control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychosocial Intervention

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca A Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5K07CA138767

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00022895

Identifier Type: -

Identifier Source: org_study_id

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