A Research Study for Latina Women With Breast Cancer

NCT ID: NCT04861896

Last Updated: 2023-11-08

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-11-07

Brief Summary

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The purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects.

The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period.

All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.

Detailed Description

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Conditions

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Cancer, Breast Cancer-related Problem/Condition Quality of Life Hormone Dependent Neoplasms Adherence, Medication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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"My Guide" (psychoeducation & self management program)

Smartphone-based program plus standard clinical care.

Group Type EXPERIMENTAL

"My Guide" (psychoeducation & self-management program)

Intervention Type BEHAVIORAL

12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.

Interventions

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"My Guide" (psychoeducation & self-management program)

12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female
* Diagnosis of breast cancer, non-metastatic, stage 0-III (A, B, or C)
* Receiving or received endocrine/hormone therapy within the last 3 years (36 months)
* At least 18 years of age
* Able to speak and read English or Spanish
* Able to provide informed consent
* Self-identify Hispanic/Latina ethnicity

Exclusion Criteria

* Stage IV or metastatic
* Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
* Diagnosis of an unmanaged psychotic disorder, bipolar disorder, dissociative disorder, or other diagnoses for which participation in this trial is either inappropriate or dangerous - this includes patients who have a life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., fibromyalgia)
* Illicit substance or alcohol dependence
* Suicidal ideation, plan, intent
* Alzheimer's, dementia, or history of stroke
* Scheduled reconstruction surgery within 1 month of any study procedures or involvement.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Betina Yanez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00201961B

Identifier Type: -

Identifier Source: org_study_id

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