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.
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.
Brief Title
A Research Study for Latina Women Undergoing Breast Cancer Treatment
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Cancer-related Problem/Condition
Quality of Life
Stress, Emotional
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
Female
Gender Based
false
Keywords
eHealth
Health Related Quality of Life
Symptom Burden
Breast Cancer
Hispanic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT04064151
Org Class
Other
Org Full Name
Northwestern University
Org Study Id
STU00201961A
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)
Outcome 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)
Outcome Description
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.
Outcome Measure
Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT)
Outcome 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)
Secondary Outcomes
Outcome Description
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.
Outcome 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)
Outcome Measure
Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
Outcome Description
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.
Outcome 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)
Outcome Measure
Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire
Outcome Description
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.
Outcome 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)
Outcome Measure
Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
Outcome Description
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.
Outcome 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)
Outcome Measure
Stress Management Skills will be evaluated with the Brief COPE Inventory
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org