A Research Study for Latina Women With Breast Cancer

Northwestern University

Status: Completed

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

Treatments: Behavioral: "My Guide" (psychoeducation & self-management program)

Study type: Interventional

Funder types: Other

Identifiers

NCT04861896

STU00201961B

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

"My Guide" (psychoeducation & self management program)

Experimental group

Description:

Smartphone-based program plus standard clinical care.

Treatment:

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