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Among Latinas and Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. However, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer.
This paper aims to describe the procedures and methods of
Study participants will be randomized to the
Recruitment began in August 2019 and is expected to be completed by August 2020. We expect to submit study results for publication by fall 2020.
PRR1-10.2196/14339
Among Latinas/Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths [
To address poor HRQoL among Latina BCSs, our team previously developed and pilot tested
To date, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer [
In light of the limited technology-assisted interventions specifically designed for Latina women undergoing active treatment for breast cancer, more studies are needed to establish the feasibility of smartphone-based interventions for Latinas during active cancer treatment [
We hypothesize that Latina women will find
This RCT is designed to assess the preliminary feasibility and efficacy of the
Study outcomes and intervention targets will be measured at study enrollment and before randomization (T1), 6 weeks postbaseline (T2), and 12 weeks postbaseline (T3). All assessment time points will consist of measures assessing our primary outcomes, intervention targets, and secondary outcomes. In addition, all participants will complete a sociodemographic questionnaire at T1, and participants randomized to the intervention condition will be asked to complete an exit survey at T3. Assessments are estimated to take approximately 35 min to complete. Participants randomized to the intervention condition will also be asked to complete brief, 3-min, weekly questionnaires throughout the course of the 12-week intervention. See section
Participants will be 60 Latina women who have been diagnosed with stage I-IIIA breast cancer, have completed surgery (eg, mastectomy and lumpectomy), and are actively receiving adjuvant treatment for breast cancer (eg, chemotherapy, radiation, and biologic therapy). We will enroll participants from the Robert H. Lurie Comprehensive Cancer Center at Northwestern Memorial Hospital, the University of Illinois Health System, and various community-based support groups sponsored by ALAS-WINGS, a Chicago-based nonprofit organization for Latina breast cancer patients.
We will identify participants through screening of the electronic medical record (EMR), and final determinations for study eligibility will be made based on a self-report questionnaire via telephone interview. To be included in the study, participants must (1) be female, because male breast cancer patients represent less than 1% of the breast cancer cases; (2) have a diagnosis of stage I-IIIA breast cancer; (3) have completed surgery for breast cancer; (4) be within any timepoint of the adjuvant treatment trajectory for breast cancer (eg, chemotherapy, radiation, surgery, and biologic therapy); (5) be at least 18 years of age; (6) be able to speak and read English or Spanish; (7) be able to provide informed consent; and (8) self-identify as Hispanic/Latina ethnicity. Participants will be excluded from the study if they (1) have a hearing, motor, visual, or voice impairment that would preclude completion of study procedures; (2) have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, or any other diagnosis for which study participation would be inappropriate or dangerous; (3) endorse suicidal ideation, plan, or intent; (4) endorse illicit substance or alcohol dependence; or (5) have been diagnosed with dementia. Patients with metastatic disease will not be included in this study, as they have more extensive treatment regimens and substantially different needs relative to patients with earlier stages of breast cancer.
Eligible participants who provide informed consent will be individually randomized using a 1:1 ratio to either the intervention condition (
All intervention participants will be assigned a trained, bilingual telecoach who will provide telecoaching using a stepped-care approach (
Module | Description of information provided | Examples |
Managing My Symptoms | Common physical and psychological symptoms patients experience during and after cancer treatment | Nausea and vomiting, fatigue, lymphedema, sadness, worry |
Managing My Emotions | Emotions commonly experienced during and after cancer treatment | Anger, anxiety, sadness/depression; improving thoughts and feelings; expressing your feelings |
Understanding Your Breast Cancer | Breast cancer, adjuvant cancer treatments and related side effects | Breast cancer and treatments overview; following doctor recommendations |
Living Well After Treatment | Maintaining a healthy lifestyle during treatment | Diet and physical activity content specific for patients with cancer |
Friends and Family | Changes in roles and responsibilities at home and work, relationships with family and friends, and daily activities during and after cancer treatment | Changes to relationships, sexual/intimacy, and at work; advice for singles; talking to your doctor |
Community and Everyday Support | Local community organizations and resources for Latinas in the Chicagoland area for additional support | Spanish support groups, transportation assistance, financial assistance |
Telecoaching stepped-care protocol.
The telecoaching calls will be brief (15 min) and focus on encouraging adherence to
All telecoaches will receive training in motivational interviewing and goal setting with a particular focus on sensitivity to issues relevant for Latina women (eg, cultural beliefs that may influence coping and health behaviors). Telecoaches will have access to participants’ app usage through a study administrative site. All telecoaching calls will be audio-recorded, and approximately 20% of the telecoaching calls will be reviewed weekly in supervision with a licensed clinical psychologist to monitor intervention fidelity.
One of the most significant additions to the intervention app is that
Each week participants will be incrementally rewarded/reinforced for the time spent using the
The smartphone app for the
Screenshot of the
Participants will be able to securely log in to the app, and participant usage and engagement with video/audio features will be captured and sent to a secure and Health Insurance Portability and Accountability Act–compliant medical school server housed at Bright Outcomes. Security measures to protect privacy threats associated with users’ computers and devices include the following measures: users are automatically logged out of intervention and assessment tools after 20 min of inactivity; any data stored locally are automatically encrypted based on the user authentication information and cannot be accessed without this information; all information collected by the app will be immediately transmitted to the secure server; and no app data will be saved to the phone’s memory.
Participants randomized to the enhanced usual care control condition will receive care as usual and printed educational materials from the National Cancer Institute related to breast cancer and survivorship [
Consistent with past research, the feasibility of
All measures will be administered in each participant’s preferred language. For assessments completed in Spanish, we will use measures that have either been previously translated to Spanish and validated or measures that were translated to Spanish for this study by IRB-approved translators.
Participants will complete a self-report sociodemographic questionnaire at T1 including questions related to age, racial background, Latina ancestry, income, employment, relationship status, educational attainment, years living in the United States, and subjective social status using the MacArthur scale [
At T1 to T3, participants will complete the Functional Assessment of Cancer Therapy-Breast (FACT-B). The FACT-B has been extensively used among breast cancer patients [
At T1 to T3, participants will complete the Breast Cancer Prevention Trial (BCPT) symptom questionnaire. The BCPT is a 25-item questionnaire that asks participants to use a 5-point response scale to rate their level of discomfort with common breast cancer–related symptoms during the past 4 weeks [
Anxiety and depressive symptoms will be measured at T1 to T3 using the Patient-Reported Outcomes Measurement Information System (PROMIS) [
At T1 to T3, participants will complete the Concerns About Recurrence Scale to assess fears about breast cancer recurrence [
Physical activity will be measured at T1 to T3 using the International Physical Activity Questionnaire (IPAQ)-short form [
Dietary intake will be measured at T1 to T3 using the Brief Dietary Assessment Tool for Latinas [
A total of 3 self-report questionnaires will be used to measure cancer-relevant self-efficacy at T1 to T3. First, the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) is a psychometrically valid 12-item measure. A total of 2 CASE-cancer subscales will be used to assess a person with cancer’s self-efficacy in communication and information seeking [
The Knowledge about Breast Cancer questionnaire will be used to assess knowledge related to treatment at T1 to T3. This scale consists of 16 true or false statements regarding general breast cancer knowledge. The average number of correct responses will be calculated. This questionnaire was previously tested with a large sample of Spanish-speaking Latina BCSs [
The Impact of Events Scale will be used to assess cancer-specific distress at T1 to T3. This measure comprises 2 subscales assessing the frequency of intrusive thoughts and avoidance following a stressful event [
Descriptive statistics will be used to characterize the overall sample, each condition, and study acceptability and demand. To examine preliminary differences in feasibility between study conditions, we will use the chi-square test, Fisher exact test, and nonparametric Mann-Whitney
For each study outcome, average changes from pre intervention to post intervention will be calculated via means (SD) and 95% CIs, and the mean changes within study condition will be converted to effect sizes. An analysis of covariance approach will be used to examine differences between the intervention and control conditions in follow-up scores, after adjusting for baseline score. Established cut-offs will also be referenced for clinically meaningful differences for the FACT-B and FACT-B subscales to identify ranges and patterns of changes in scores across conditions from baseline to follow-up.
All study data will be managed and stored in Research Electronic Data Capture (REDCap), a secure Web-based research data management system hosted at Northwestern University. All IRB-approved research team members will have access to REDCap. REDCap will be used to organize EMR data and to administer all study questionnaires. The
Recruitment began in July 2019 and is expected to be completed by August 2020. We expect to submit study results for publication by fall 2020.
The aim of the
Compared with the first version of the
A few limitations of the study protocol warrant discussion. First, because the focus of this study is on breast cancer patients who are in active treatment, long-term cancer survivors will not be enrolled in this study, which limits study generalizability. In addition, women who are preparing for surgery will not be included in this study. However,
There are several areas for future directions. If found feasible, future studies should establish the efficacy of
Findings from this second study of the
Peer-reviewer report from the Chicago Cancer Health Equity Collaborative.
breast cancer survivor
Breast Cancer Prevention Trial
Communication and Attitudinal Self-Efficacy scale for cancer
computer adaptive test
electronic medical record
Functional Assessment of Cancer Therapy-Breast
Functional Assessment of Cancer Therapy-General
health-related quality of life
institutional review board
International Physical Activity Questionnaire
Patient-Reported Outcomes Measurement Information System
randomized controlled trial
Research Electronic Data Capture
None declared.