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A Research Study for Latina Women After Breast Cancer Treatment

NCT03645005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-08-13

No results posted yet for this study

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 survivors.

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 an 8-week period.

Participants are randomized into either an intervention application (described above) or a control application (health information and health promotion strategies). Aside from using the Smartphone application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 8-week follow-up.

Conditions

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

Interventions

BEHAVIORAL

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

"My Guide" is a Smartphone application incorporating elements informed by the extant literature, designed to improve quality of life and symptom burden among Hispanic breast cancer survivors. "My Guide" components are designed to improve breast cancer knowledge, cancer-relevant self-efficacy, stress and symptom management skills, Both intervention and active comparator conditions are administered to participants for 8 weeks.

BEHAVIORAL

"My Health" (health education program)

"My Health" is a health promotion Smartphone application with health education content on nutrition, and general advice on lifestyle choices and prevention. The "My Health" control content was based on similar content tested in other psychosocial interventions with cancer survivors. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Betina Yanez, Ph.D. · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2019-04-24
Completion
2019-05-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03645005 on ClinicalTrials.gov