A Research Study for Latina Women After Breast Cancer Treatment
Completed · Not applicable
Conditions studied: Cancer-related Problem/Condition, Quality of Life, Stress, Emotional
In brief
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.
Key facts
- Study ID
- NCT03645005
- Run by
- Northwestern University
- People needed
- 80
- Starts
- 2015-03-25
- Expected to finish
- 2019-05-15
- Last updated by the study team
- 2020-08-13
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
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
- Completed active treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowed)
- No current evidence of disease
- Within 3 to 24 months post-active 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 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.
Where it is running
- University of Illinois Cancer Center — Chicago, Illinois, United States
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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