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Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy

NCT ID: NCT01738685

Last Updated: 2016-11-15

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.

Detailed Description

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Conditions

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Breast Cancer Female

Keywords

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Breast Cancer. Adjuvant Endocrine therapy.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control.

Nutritional Education.

Group Type OTHER

Nutritional Education.

Intervention Type OTHER

Behavioral Intervention

Behavioral Intervention.

Group Type OTHER

Behavioral Intervention.

Intervention Type BEHAVIORAL

Interventions

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Behavioral Intervention.

Intervention Type BEHAVIORAL

Nutritional Education.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 50.
* Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for \> 0 months and \< 6 months).
* Possess a household or cell telephone.
* Ability to provide informed consent.

Exclusion Criteria

* Clinically significant cognitive impairment.
* Communication barrier limiting ability to participate in telephone assessments.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Van Londen, Gijsberta

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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G van Londen, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO12050094

Identifier Type: -

Identifier Source: org_study_id