Clinical trial NCT04861896: A Research Study for Latina Women With Breast Cancer
Official title: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Cancer-related Problem/Condition
Quality of Life
Hormone Dependent Neoplasms
Adherence, Medication
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of My Guide: Usefulness
timeFrame: T3 (immediately following 12 week intervention)
measure: Acceptability of My Guide: Satisfaction
timeFrame: T3 (immediately following 12 week intervention)
measure: Acceptability of My Guide: Learnability
timeFrame: T3 (immediately following 12 week intervention)
measure: Acceptability of My Guide: Usability
timeFrame: T3 (immediately following 12 week intervention)
measure: Demand of My Guide: Recruitment Rate
timeFrame: 12 weeks
measure: Demand of My Guide: Retention Rate
timeFrame: 12 weeks
measure: Participant use of My Guide: Number of Login's
timeFrame: 12 weeks
measure: Participant use of My Guide: Duration of Usage
timeFrame: 12 weeks
measure: Participant use of My Guide: Content Accessed
timeFrame: 12 weeks
measure: Change in Medication adherence will be assessed primarily with the Adherence to Refills and Medication Scale (ARMS).
timeFrame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Secondary outcomes:
measure: Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
timeFrame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
measure: Change in Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
timeFrame: T1 (prior to starting intervention), T2 (6 weeks into intervention), T3 (immediately following 12 week intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: