A Research Study for Latina Women Undergoing Breast Cancer Treatment

NCT04064151 | Completed

• 1 other identifier: STU00201961A
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of a developed psychosocial eHealth intervention on the proposed primary outcomes, health-related quality of life and symptom burden, among Hispanic breast cancer patients. The intervention components include breast cancer 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. Participants are randomized into either an intervention application (described below) or standard treatment. 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.

Conditions

Cancer-related Problem/Condition; Quality of Life; Stress, Emotional

Keywords

eHealth; Health Related Quality of Life; Symptom Burden; Breast Cancer; Hispanic

Outcome Measures

Primary Outcomes (2)

• Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)

  The FACT-B has been used extensively to measure HRQoL, and has been translated to and validated in Spanish. The FACT-B assesses participant's wellbeing in physical, emotional, social, functional, and breast cancer related concerns in the last seven days using a five-point response scale.

  HRQoL will be first assessed at baseline (T1), initial HRQoL changes will be assessed at 6 weeks post-baseline (T2), and finally any additional HRQoL changes will be captured 12 weeks post-baseline (T3)

• Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT)

  The BCPT measures participants' symptom burden. The BCPT asks participants to report their level of discomfort with 25 breast cancer related symptoms during the past four weeks using a five-point response scale.

  Symptom Burden will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3)

Secondary Outcomes (4)

• Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)

  Cancer-specific distress will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3)

• Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire

  Breast Cancer Knowledge will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3)

• Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)

  Breast Cancer Related Communication and Attitudinal Self-Efficacy will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3)

• Stress Management Skills will be evaluated with the Brief COPE Inventory

  Stress Management Skills will be first assessed at baseline (T1), initial changes will be assessed at 6 weeks post-baseline (T2), and finally any additional changes will be captured 12 weeks post-baseline (T3)

Study Arms (2)

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

EXPERIMENTAL

Smartphone-based program plus standard clinical care.

Behavioral: My Guide

Standard Medical Care

NO INTERVENTION

Standard clinical care with no smartphone intervention.

Interventions

My Guide BEHAVIORAL

12-week long health promotion Smartphone application

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

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Diagnosis of breast cancer, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either radiation or chemotherapy is required as an additional treatment to surgery
• Currently undergoing cancer treatment \[e.g., surgery, chemotherapy, radiation, or combination of the two or three\]
• at least 21 years of age
• Able to speak and read English or Spanish
• Able to provide informed consent
• Elevated score on breast cancer symptom burden and HRQoL, measured by the Functional Assessment of Cancer Therapy-Breast questionnaire using an established cut-off score for clinically meaningful, compromised HRQoL
• Self-identified Hispanic/Latina ethnicity.

You may not qualify if:

• 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 diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Breast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: September 10, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)