Elsevier

Contemporary Clinical Trials

Volume 65, February 2018, Pages 61-68
Contemporary Clinical Trials

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors

https://doi.org/10.1016/j.cct.2017.11.018Get rights and content

Abstract

Breast cancer is the most commonly diagnosed non-skin cancer in women and the leading cause of death among Hispanic women living in the United States. Relative to non-Hispanic white women, Hispanic women report poorer health related quality of life (HRQoL) after treatment. Although eHealth interventions delivered via Smartphones are a viable approach to addressing supportive care accessibility issues while also integrating multidisciplinary approaches for improving HRQoL, few eHealth interventions have been developed that specifically target Hispanic breast cancer survivors (BCS). This manuscript describes the methodology of a multi-site, randomized controlled behavioral trial investigating the feasibility and preliminary efficacy of a Smartphone application aimed at improving HRQoL and cancer-specific distress among Hispanic BCS. Participants will be randomized to receive the intervention application, My Guide (psychoeducation & self-management program), or the health education control condition application, My Health (health education), for six weeks. All participants will also receive weekly telecoaching to enhance adherence to both control and intervention conditions. We will measure the study's primary outcomes, general and disease-specific HRQoL and cancer-specific distress, at three time points: prior to, immediately after the intervention, and eight weeks after initial application use. My Guide may have the potential to improve HRQoL, and to address issues of limited access to supportive care among Hispanic women recovering from breast cancer treatment.

Introduction

Among Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is the leading cause of death [1]. Approximately 1 in 3 Hispanics will receive a diagnosis of cancer and among Hispanic women, breast cancer is the most commonly diagnosed type of cancer [1]. Relative to non-Hispanic Whites, Hispanics are underrepresented in oncology clinical trials [2] and few interventions have been developed specifically to enhance access to supportive care for Hispanic women diagnosed with breast cancer [3].

Breast cancer survivors (BCS) often experience symptoms related to their diagnosis and treatment that result in poor health-related quality of life (HRQoL) outcomes both during and following treatment. Common side effects of breast cancer treatments may include fatigue, hot flashes, depressive symptoms, sleep changes, changes in sexual functioning, and hair loss. Relative to non-Hispanic White women, Hispanic women report poorer HRQoL after completing active treatment for breast cancer, even when adjusting for socioeconomic status [4], [5]. Poorer HRQoL among Hispanic BCS may in part be due to an increased level of stressors and barriers to care such as language barriers, lack of information on survivorship, as well as culturally driven beliefs and attitudes such as simpatia and fatalism [4], [6], [7], [8]. Additionally, poor HRQoL has been linked to lower adherence to follow-up care and anti-cancer medications. Therefore, culturally tailored, supportive oncology interventions to improve patient-centered outcomes are an important first step to improving follow-up care, and ultimately sustaining the long-term health of Hispanic women diagnosed with breast cancer [9], [10], [11].

The past decade has seen an increase in observational research focusing on the HRQoL of women diagnosed with breast cancer, including Hispanic women, [12], [13], [14], [15], [16], [17] as well as a handful of studies documenting the efficacy of supportive interventions to improve HRQoL among Hispanic women diagnosed with cancer [13], [16]. While preliminary findings suggest that increasing cancer knowledge, self-efficacy in communication, and self-management skills can improve HRQoL outcomes in this population [6], [17], [18], [19], [20], [21], [22], the extant literature is limited by in-person or phone-based treatment modalities. These approaches can be more costly, time intensive, and less scalable than interventions facilitated with Smartphones [23].

Over the past decade, there has been a proliferation of Smartphone-based applications that deliver evidence-based treatments for health management [23], [24], [25], [26]. Although this method is innovative and has potential for widespread dissemination, no Smartphone-based intervention to date has been developed to improve patient-centered outcomes among Hispanic breast cancer survivors. Hispanics own Smartphones and seek health information online from mobile devices at similar or higher rates than other racial/ethnic groups in the U.S [27]. Therefore, Smartphone-based interventions offer an opportunity to overcome obstacles to accessing in-person supportive care and services that can be linguistically and culturally tailored and provide skills to improve HRQoL [27], [28]. Studies have yet to determine the efficacy of a Smartphone-based intervention in improving outcomes among this understudied patient population.

This paper describes the procedures and methodology of a multi-site, randomized controlled behavioral trial investigating the preliminary feasibility and efficacy of a Smartphone-based intervention to reduce cancer-specific distress and improve HRQoL compared to a health education control condition among Hispanic BCS. The intervention will be administered over the course of six weeks to a sample of 80 English and Spanish-speaking Hispanic BCS.

Section snippets

Hypotheses

We hypothesize that Hispanic BCS will find the Smartphone application, My Guide, a feasible tool for accessing post-treatment relevant information, as well as for learning strategies to improve cancer-relevant self-efficacy, stress, communication and symptom management. Furthermore, we expect that, in comparison to the control condition, My Guide will have a measurable, positive improvement on Hispanic women's HRQoL and cancer-specific distress.

Study design

The study design was informed by the CONSORT

Intervention content, development and final version

The content in the My Guide intervention was informed by the literature on eHealth interventions models of stress and coping, the extant literature on psychosocial adaptation during and after breast cancer, [25], [35] and our preliminary findings suggest that cancer knowledge, stress awareness and management, social support, and enhanced communication and intimacy can improve symptom burden and HRQoL outcomes in this population [6], [17], [18], [19], [20], [21], [22]. The content in My Guide

Data collection

Data for our study will be collected during eligibility screening, immediately before, after and during the six-week intervention, and eight weeks after the baseline assessment. The screening questionnaire is administered over the phone to determine initial eligibility. Eligible participants are scheduled for an in-person meeting where they complete a sociodemographics questionnaire and a psychosocial baseline assessment. During the intervention participant application usage is collected, as

Discussion

The goal of this study is to improve the health-related quality of life of Hispanic BCS. In light of the increasing number of Hispanics accessing the Internet mostly through Smartphones, we selected this technology-based platform to deliver our intervention. Smartphone-based interventions have the benefit of increasing access to hard-to-reach patient populations such as minorities, are scalable, and can be accessed by the patient at any time and location. However, there is limited evidence on

Acknowledgements

Support for this project was provided by National Cancer Institute of the National Institutes of Health under Award Number NCI U54 CA203000. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

References (58)

  • M.S. Chen et al.

    Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual

    Cancer

    (2014)
  • B. Yanez et al.

    Quality of life among Latina breast cancer patients: a systematic review of the literature

    J. Cancer Surviv.

    (2011)
  • A. Nápoles-Springer et al.

    Developing a culturally competent peer support intervention for Spanish-speaking Latinas with breast cancer

    J. Immigr. Minor. Health

    (2009)
  • L.C. Gallo et al.

    Resiliency in the face of disadvantage: do Hispanic cultural characteristics protect health outcomes?

    J. Pers.

    (2009)
  • B.L. Andersen et al.

    Psychologic intervention improves survival for breast cancer patients: a randomized clinical trial

    Cancer

    (2008)
  • B.L. Andersen et al.

    Biobehavioral, immune, and health benefits following recurrence for psychological intervention participants

    Clin. Cancer Res.

    (2010)
  • Y. Molina et al.

    Breast cancer interventions serving US-based Latinas: current approaches and directions

    Women's Health (Lond. Engl.)

    (2013)
  • K. Ashing et al.

    Telephonic-based trial to reduce depressive symptoms among Latina breast cancer survivors

    Psychooncology

    (2014)
  • C.L. Rush et al.

    Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention

    Qual. Life Res.

    (2015)
  • A. Ramirez et al.

    Reducing time-to-treatment in underserved Latinas with breast cancer: the six cities study

    Cancer

    (2014)
  • A.M. Napoles et al.

    Nuevo amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in latinas with breast cancer

    Am. J. Public Health

    (2015)
  • B. Yanez et al.

    Predictors of psychological outcomes in a longitudinal study of Latina breast cancer survivors

    Psychol. Health

    (2016)
  • K.T. Ashing-Giwa et al.

    Examining predictive models of HRQOL in a population-based, multiethnic sample of women with breast carcinoma

    Qual. Life Res.

    (2007)
  • K. Ashing-Giwa

    The contextual model of HRQoL: a paradigm for expanding the HRQoL framework

    Qual. Life Res.

    (2005)
  • K.T. Ashing-Giwa et al.

    Understanding the breast cancer experience of Latina women

    J. Psychosoc. Oncol.

    (2006)
  • K. Graves et al.

    Through the lens of culture: quality of life among Latina breast cancer survivors

    Breast Cancer Res. Treat.

    (2012)
  • P.A. Ganz et al.

    Physical and psychosocial recovery in the year after primary treatment of breast cancer

    J. Clin. Oncol.

    (2011)
  • Y. Leykin et al.

    Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations

    Psychooncology

    (2012)
  • B. Yanez et al.

    Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer

    Cancer

    (2015)
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