Clinical trial NCT03645005: A Research Study for Latina Women After Breast Cancer Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Quality of Life
Stress, Emotional
Keywords: eHealth
Health Related Quality of Life
Symptom Burden
Breast Cancer
Hispanic
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 the period at the end of active treatment which is a critical period to intervene to provide skills and tools to assist with this transition. 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 completing 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 in two-phases to develop and test a Smartphone-based intervention that can be disseminated to cancer survivors at a relatively low cost. The first phase is intended to create an eHealth intervention designed to improve cancer-related symptom burden and HRQOL. The second phase is designed as an 8-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.

Eligibility criteria: Inclusion Criteria:

1. Female
2. 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
3. Completed active treatment for breast cancer (surgery, chemotherapy and/or radiation therapy, current hormonal treatment allowed)
4. No current evidence of disease
5. Within 3 to 24 months post-active treatment \[e.g., surgery, chemotherapy, radiation, or combination of the two or three\]
6. at least 21 years of age
7. Able to speak and read English or Spanish
8. Able to provide informed consent
9. 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
10. Self-identified Hispanic/Latina ethnicity.

Exclusion Criteria:

1. Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
2. 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)
3. Illicit substance or alcohol dependence
4. Suicidal ideation, plan, intent
5. Alzheimer's, dementia or history of stroke
6. Scheduled reconstruction surgery within 1 month of any study procedures or involvement.

Primary outcomes:
measure: Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: 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 8 weeks post-baseline (T3)
measure: Symptom Burden will be evaluated with The Breast Cancer Prevention Trial symptom questionnaire (BCPT)
timeFrame: 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 8 weeks post-baseline (T3)
Secondary outcomes:
measure: Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
timeFrame: 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 8 weeks post-baseline (T3)
measure: Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire
timeFrame: 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 8 weeks post-baseline (T3)
measure: Breast Cancer Related Communication and Attitudinal Self-Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
timeFrame: 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 8 weeks post-baseline (T3)
measure: Stress Management Skills will be evaluated with the Brief COPE Inventory
timeFrame: 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 8 weeks post-baseline (T3)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Betina Yanez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baik SH, Oswald LB, Buscemi J, Buitrago D, Iacobelli F, Perez-Tamayo A, Guitelman J, Penedo FJ, Yanez B. Patterns of Use of Smartphone-Based Interventions Among Latina Breast Cancer Survivors: Secondary Analysis of a Pilot Randomized Controlled Trial. JMIR Cancer. 2020 Dec 8;6(2):e17538. doi: 10.2196/17538.