A Research Study for Latina Women With Breast Cancer

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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)

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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