mHealth to Improve Medication Adherence Among Latina Breast Cancer Patients Experiencing Non-Medical Drivers of Health
Background: Hormonal therapy (HT) is highly effective for nearly all breast cancer patients with hormone receptor-positive tumors, which are about 80% of all breast cancer diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of mortality nearly in half during the second decade after diagnosis. Despite proven benefits, 33% of women who are prescribed HT do not take it as prescribed (<80% take their daily dosage). Latina patients are disproportionately affected by non-medical drivers of health (NMDoH) that keep them from adhering to HT and are at higher risk of breast cancer recurrence and mortality.
Objective: The goal of this 4-year randomized controlled study is to assess the effectiveness of the bilingual, culturally tailored, interactive HT Helper App, in combination with patient navigation (PN), on improving adherence to HT among Latina breast cancer patients experiencing any NMDoH barriers, such as income, health insurance, education, health literacy, and language, that impact their medication adherence. This theory-based intervention will increase patient education, enhance self-efficacy, facilitate communication with the medical team and coordination of resources to address NMDoH barriers, and help patients develop self-care skills for optimal adherence to HT, ensuring patients the most equitable treatment outcomes possible, including improvement in quality of life, survival, and life expectancy.
Specific Aims/Hypothesis: 1) Conduct a 3-group randomized study to assess the effectiveness of the HT Helper App + PN vs. PN alone vs. usual care, on HT adherence; and 2) Assess the effect of each study condition on patient self-efficacy to identify side effects, use self-care to manage side effects, and communicate with the medical team. We hypothesize that the HT Helper App + PN and the PN alone groups will have greater rates of HT adherence and higher patient self-efficacy than the usual care group; with the HT Helper App + PN achieving better results than both PN alone and the usual care groups.
Study Design. The proposed study involves a parallel 3-group randomized controlled trial with 5-time assessments (baseline, 3, 6, 12, and 18 months) and will enroll 159 breast cancer patients who are prescribed HT and are attending the breast clinic at the Mays Cancer Center at UT Health San Antonio. Intervention components are based on Social Cognitive Theory and elements of Motivational Interviewing.
Cancer Relevance. This innovative multi-level intervention will improve adherence to HT by addressing NMDoH and promote equitable breast cancer outcomes, including reduced recurrence and improved quality of life, overall survival, and life expectancy among underserved Latina patients. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using oral anticancer medications.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Study Coordinator
- Número de telefone: 210-567-6523
- E-mail: HTHelper@uthscsa.edu
Estude backup de contato
- Nome: Research Assistant
- Número de telefone: 210-567-6523
- E-mail: HTHelper@uthscsa.edu
Locais de estudo
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Texas
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San Antonio, Texas, Estados Unidos, 78229
- Recrutamento
- The University of Texas Health Science Center at San Antonio
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Contato:
- Patricia Chalela, DrPH
- Número de telefone: 210-562-6513
- E-mail: chalela@uthscsa.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
English- or Spanish-speaking Latina patients aged 18 and older who:
a) are diagnosed with hormone receptor-positive breast cancer and prescribed HT; b) within 1 to 24 months of starting HT; c) are experiencing any NMDoH by the Avanzando Center NMDoH Screener; d) are able to read; e) own a smartphone and are able to send and receive text messages and access the Internet; and f) are able to provide informed consent to participate in the study.
Exclusion Criteria:
Not meeting the criteria above, or patients who:
a) are not Latina and are younger than 18 years; b) are not receiving HT treatment; c) with more than 24 months of starting treatment; d) do not experience any NMDoH by the Avanzando Center NMDoH Screener; e) are unable to read; f) do not own a smartphone and are unable to send and receive text messages and access the Internet; g) are unable to respond to text messages and questions or unable to download the study app; h) are unable to provide informed consent due to a mental, emotional, or physical handicap that keeps them from understanding the consent information; i) are unable to see the app and study materials and videos (i.e., are blind, deaf); and j) currently participating in a psychosocial intervention trial or individual/group psychotherapy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group 1: HT Helper App + Patient Navigation
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HT Helper app plus patient navigation support to promote hormone therapy adherence among breast cancer patients experiencing NMDoH barriers
Usual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center
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Experimental: Group 2: Patient Navigation Alone
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Usual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center
Patient navigation support to address NMDoH barriers impacting hormone therapy adherence
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Outro: Group 3: Usual Care
Control group
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Usual care provided to patients who are prescribed hormone therapy and attend the Breast Clinic at the Mays Cancer Center
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence to hormone therapy
Prazo: From enrollment to end of the intervention at 18 months
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Adherence to HT, defined as the percentage of doses taken as prescribed, with optimal adherence considered at ≥80%.
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From enrollment to end of the intervention at 18 months
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Self-efficacy for Appropriate Medication Use Scale (SEAMS)
Prazo: From enrollment to the end of the intervention at 18 months
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Self-efficacy for medication adherence will be measured using the Self-Efficacy for Appropriate Medication Use Scale (SEAMS), a validated 13-item instrument with three-point Likert scale response options ranging from 1=not confident to 3=very confident.Total scores range from 13-39 with a higher score indicating better confidence in self-efficacy.
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From enrollment to the end of the intervention at 18 months
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Social support
Prazo: From enrollment to the end of the intervention at 18 months
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Social support will be measured by the Multidimensional Scale of Perceived Social Support.
This is a validated instrument with 12 questions rating three sources of support (family, friends, and significant others).
Response options include a 7-point Likert scale ranging from 1=very strongly disagree to 7=very strongly agree.
Total scores range from 12-84 with a higher score indicating stronger perceived social support.
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From enrollment to the end of the intervention at 18 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hormone therapy medication side effects
Prazo: From enrollment to the end of the intervention at 18 months
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HT side effects will be assessed with the validated BCPT Symptoms Scale, which includes 25 of the most common cancer treatment symptoms, with response options using a 5-item Likert scale ranging from 0=not at all to 4=extremely.
Total scores range from 0-72 with a higher score indicating more side effects experienced
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From enrollment to the end of the intervention at 18 months
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Quality of life questionnaire
Prazo: From enrollment to the end of the intervention at 18 months
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Quality of life (QoL) will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire.
This questionnaire is well validated and has been used in multiple studies around the world.The FACT-G Version 4 is a 27-item, 5-point Likert scale questionnaire (0=Not at all to 4=Very much) measuring cancer patient quality of life, scoring between 0 and 108, where higher scores indicate better QoL.
It is scored by reversing negatively phrased items, summing 4 subscales (Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being), and requires >80% completion.
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From enrollment to the end of the intervention at 18 months
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Depression
Prazo: From enrollment to the end of the intervention at 18 months
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Depression will be assessed by the Patient Health Questionnaire (PHQ-8), an 8-item self-administered screening tool that has been validated in large clinical and population studies.
Items are scored from 0=Not at all to 3=Nearly every day.
Total scores range from 0-24 with a higher score indicating a higher degree of depression
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From enrollment to the end of the intervention at 18 months
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Anxiety
Prazo: From enrollment to the end of the intervention at 18 months
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Anxiety will be assessed by the G 7-item scale (GAD-7), a validated tool used in clinical practice and research studies to assess the severity of anxiety.
Each item is scored from 0=Not at all sure to 3=Nearly every day.
Total scores range from 0-21 with a higher score indicating more anxiety.
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From enrollment to the end of the intervention at 18 months
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Patricia Chalela, DrPH, MPH, The University of Texas Health Science Center at San Antonio
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20230626HU
- CHERC-MSI-22-182-01 (Número de outro subsídio/financiamento: American Cancer Society)
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