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A Research Study for Latina Women Undergoing Breast Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064151
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Betina Yanez, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Quality of Life Stress, Emotional Behavioral: My Guide Not Applicable

Detailed Description:

Among Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is the leading cause of death whereas cardiovascular disease is the leading cause of death for African Americans and non-Hispanic Whites (NHWs). Hispanics also experience substantially lower rates of 5-year cancer-specific survival relative to non-Hispanic Whites (NHWs). Hispanic cancer patients in the U.S. also report significantly worse cancer-related symptom burden and health-related quality of life (HRQOL) than NHWs, even after adjusting for socioeconomic factors.

Despite this, very few randomized, intervention studies have specifically targeted cancer-related symptom burden and HRQOL outcomes among Hispanic women, especially during active treatment, which is a critical period to intervene to provide skills and tools to assist with cancer care. Innovative approaches to providing interventions such as Smartphone technology are especially important for this patient population. Ubiquitous Smartphone use among ethnic minorities in the US provide a unique opportunity to implement a pragmatic technology- and evidence-based psychosocial intervention that overcomes some access to care barriers as well as time and logistical constraints. Furthermore, given that Hispanics own Smartphones and seek health information online from a mobile device at similar or higher rates than other groups in the U.S., Smartphone interventions offer an opportunity to overcome obstacles to accessing resources and services that can be culturally informed and provide skills to improve symptom burden and HRQOL.

This study aims to create and evaluate a culturally informed eHealth psychoeducational and psychosocial intervention for English or Spanish-speaking Hispanic women undergoing treatment for breast cancer. This intervention is grounded in evidence-based paradigms to improve the proposed Primary Outcomes: Cancer-Related Symptom Burden and HRQOL and the proposed Secondary Outcomes: usability and markers the intervention use. This study is designed to develop and test a Smartphone-based intervention that can be disseminated to cancer patients at a relatively low cost. This study designed as a 12-week randomized trial intended to evaluate the eHealth intervention when compared to a control condition. It is hypothesized that the eHealth intervention will significantly improve cancer-related symptom burden and HRQOL compared to the control condition.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: "My Guide" (psychoeducation & self-management program)
Smartphone-based program plus standard clinical care.
Behavioral: My Guide
12-week long health promotion Smartphone application

No Intervention: Standard Medical Care
Standard clinical care with no smartphone intervention.



Primary Outcome Measures :
  1. Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: 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) ]
    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.

  2. Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT) [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES) [ Time Frame: 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) ]
    The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer and has been translated and validated with Spanish-speaking participants.

  2. Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire [ Time Frame: 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) ]
    This questionnaire has been tested with Spanish-speaking Hispanic breast cancer survivors, it is made up of 16 true and false questions regarding general breast cancer knowledge.

  3. Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) [ Time Frame: 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) ]
    The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.

  4. Stress Management Skills will be evaluated with the Brief COPE Inventory [ Time Frame: 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) ]
    The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064151


Contacts
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Contact: Betina Yanez, PhD 312-503-5341 betina.yanez@northwestern.edu
Contact: Diana Buitrago 312-860-3575 diana.buitrago@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Diana Buitrago    312-503-2866    diana.buitrago@northwestern.edu   
Sponsors and Collaborators
Northwestern University
  Study Documents (Full-Text)

Documents provided by Betina Yanez, Northwestern University:
Informed Consent Form  [PDF] March 11, 2019

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Responsible Party: Betina Yanez, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04064151    
Other Study ID Numbers: STU00201961A
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Betina Yanez, Northwestern University:
eHealth
Health Related Quality of Life
Symptom Burden
Breast Cancer
Hispanic
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms