Digital Health Program for Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami Sylvester Comprehensive Cancer Center
Disqualifiers: Metastatic cancer, Schizophrenia, Bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile-phone-based) program to improve lifestyle behaviors (physical activity, dietary intake) among Hispanic female cancer survivors and adult daughters.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Con Cariño, Abuelita for breast cancer survivors?
Research on similar smartphone-based interventions, like the My Guide app, shows they can improve quality of life and reduce symptom burden for Latina breast cancer survivors. These apps are culturally informed and provide evidence-based information, which suggests that digital health programs can be effective in supporting breast cancer survivors.
12345Is the Digital Health Program for Breast Cancer Survivors safe for humans?
The studies on the My Guide and My Health smartphone applications, which are part of the Digital Health Program for Breast Cancer Survivors, show that these apps are feasible and acceptable for use among Latina breast cancer survivors, with no reported safety concerns.
24567How is the treatment 'Con Cariño, Abuelita' different from other treatments for breast cancer survivors?
The 'Con Cariño, Abuelita' treatment is unique because it is a digital health program specifically designed for breast cancer survivors, focusing on culturally informed support through a smartphone app. This approach is novel as it targets Latina breast cancer survivors, aiming to improve their quality of life and reduce symptom burden by providing accessible, culturally relevant information and support.
23458Eligibility Criteria
This trial is for Hispanic female cancer survivors living in South Florida, who are overweight and have had breast (stages I-III), endometrial or ovarian cancer (stages I-II). They must have completed active treatment and engage in less than 150 minutes of moderate physical activity per week. Participants also need to be grandmothers with internet access on a mobile device. Adult daughters of these survivors can join if they're over 21 and have a child under 16.Inclusion Criteria
You live in South Florida.
I speak English or Spanish.
Owns a mobile device with internet access (e.g., smartphone, tablet)
+8 more
Exclusion Criteria
I cannot do physical activities on my own due to a severe health condition.
I am still undergoing treatment for my condition.
My cancer has spread to distant parts of my body.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants access a digital lifestyle program with 8 modules over 10-12 weeks
10-12 weeks
Digital access, no in-person visits
Follow-up
Participants are monitored for changes in physical activity and dietary intake
Up to 3 months
Participant Groups
'With Love, Grandma' is a digital program aimed at improving lifestyle behaviors like physical activity and diet among Hispanic female cancer survivors and their adult daughters. The study will evaluate how practical, acceptable, and effective this web and mobile-phone-based intervention is.
2Treatment groups
Experimental Treatment
Active Control
Group I: With Love, Grandma ("Con Cariño, Abuelita") GroupExperimental Treatment1 Intervention
Cancer survivor-Daughter dyads randomized to the With Love, Grandma ("Con Cariño, Abuelita") group will access a digital lifestyle program that includes 8 modules of didactic, behavioral, and family communication/parenting/grandparenting content from smartphones over the course of 10-12 weeks.
Group II: Control GroupActive Control1 Intervention
This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of Miami Sylvester Comprehensive Cancer CenterLead Sponsor
The V Foundation for Cancer ResearchCollaborator
References
An e-health strategy to facilitate care of breast cancer survivors: A pilot study. [2022]Innovative e-health strategies are emerging, to tailor and provide convenient, systematic and high-quality survivorship care for an expanding cancer survivor population. This pilot study tests the application of an e-health platform, "Healthy.me," in a breast cancer survivor cohort at Liverpool and Macarthur Cancer Therapy Centres, New South Wales, Australia.
Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors. [2021]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.
Effects of smartphone interventions on cancer knowledge and coping among Latina breast cancer survivors: Secondary analysis of a pilot randomized controlled trial. [2023]Objective: The My Guide smartphone application was developed to improve quality of life and symptom burden (primary outcomes) for Latina breast cancer survivors (BCS) and tested in a pilot randomized controlled trial compared to an attention-control condition (My Health smartphone application). This secondary analysis examined effects on breast cancer knowledge, coping, and cancer-related self-efficacy (intervention targets).Method: Latina BCS (N = 78) were randomized to My Guide or My Health for six weeks. Linear mixed-effects modeling evaluated the effects of time and study condition on the intervention targets. Effects by engagement were explored. Results: Both conditions showed improved breast cancer knowledge (p < 0.001), with a trend for greatest improvement among My Guide high users (p = 0.082). My Guide participants reported less self-blame overall than My Health participants (p = 0.020). There were no effects on cancer-related self-efficacy (ps > 0.05). Conclusion: Culturally-informed smartphone applications may enhance breast cancer knowledge and promote adaptive coping among Latina BCS.
Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. [2021]Latina breast cancer survivors (BCS) report more symptom burden and poorer health-related quality of life than non-Latina BCS. However, there are few evidence-based and culturally informed resources that are easily accessible to this population. This study aimed to establish the feasibility and preliminary efficacy of the My Guide and My Health smartphone applications among Latina BCS. Both applications are culturally informed and contain evidence-based information for reducing symptom burden and improving health-related quality of life (My Guide) or healthy lifestyle promotion (My Health).
Patterns of Use of Smartphone-Based Interventions Among Latina Breast Cancer Survivors: Secondary Analysis of a Pilot Randomized Controlled Trial. [2021]Latina breast cancer survivors experience poorer health-related quality of life (HRQoL), greater symptom burden, and more psychosocial needs compared to non-Latina breast cancer survivors. eHealth platforms such as smartphone apps are increasingly being used to deliver psychosocial interventions to cancer survivors. However, few psychosocial eHealth interventions have been developed specifically for Latina breast cancer survivors. Further, little is known about how Latinas, in general, engage with eHealth interventions and whether specific participant characteristics are associated with app use in this population. We evaluated the use of 2 culturally informed, evidence-based smartphone apps for Latina breast cancer survivors-one that was designed to improve HRQoL and reduce symptom burden (My Guide) and the other to promote healthy lifestyle behaviors (My Health).
Analysing breast cancer survivors' acceptance profiles for using an electronic pillbox connected to a smartphone application using Seintinelles, a French community-based research tool. [2022]Introduction: Up to 50% of breast cancer (BC) survivors discontinue their adjuvant endocrine therapy (AET) before the recommended 5 years, raising the issue of medication non-adherence. eHealth technologies have the potential to support patients to enhance their medication adherence and may offer an effective way to complement the healthcare. In order for eHealth technologies to be successfully implemented into the healthcare system, end-users need to be willing and accepting to use these eHealth technologies. Aim: This study aims to evaluate the current usability of eHealth technologiesin and to identify differences in BC SURVIVORS BC survivors accepting a medication adherence enhancing eHealth technology to support their AET to BC survivors that do not accept such a medication adherence enhancing eHealth technology. Methods: This study was conducted in 2020 including volunteering BC survivors belonging to the Seintinelles Association. Eligible participants were women, diagnosed with BC within the last 10 years, and been exposed to, an AET. Univariable and multivariable logistic regression analyses were performed to investigate medication adherence enhancing eHealth technology acceptance profiles among BC survivors. The dependent variable was defined as acceptance of an electronic pillbox connected to a smartphone application (hereafter: medication adherence enhancing eHealth technology). Results: Overall, 23% of the participants already use a connected device or health application on a regular basis. The mean age of the participants was 52.7 (SD 10.4) years. In total, 67% of 1268 BC survivors who participated in the survey declared that they would accept a medication adherence enhancing eHealth technology to improve their AET. BC survivors accepting a medication adherence enhancing eHealth technology for their AET, are younger (OR = 0.97, 95% CI [0.95; 0.98]), do take medication for other diseases (OR = 0.31, 95% CI [0.13; 0.68]), already use a medication adherence enhancing eHealth technology or technique (OR = 1.74, 95% CI [1.06; 2.94]) and are willing to possess or currently possess one or more connected devices or health applications (OR = 2.89, 95% CI [2.01; 4.19]). Conclusion: Understanding acceptance profiles of BC survivors is fundamental for conceiving an effective eHealth technology enhancing AET among BC survivors. Hence, such profiling will foster the development of personalized medication adherence enhancing eHealth technology.
Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. [2021]Hispanic breast cancer survivors (BCS) are at high risk for experiencing poor health-related quality of life (HRQoL) after completion of active breast cancer treatment. Therefore, there is a need to develop culturally tailored interventions for Hispanic BCS. To date, there have been limited interventions that have demonstrated that increasing cancer-related knowledge, self-efficacy in communication, and self-management skills can improve HRQoL among Hispanic BCS. These interventions have been delivered in person or by phone, which may be burdensome for Hispanic BCS. To facilitate intervention delivery, we developed My Guide, a Smartphone application aimed at improving HRQoL among Hispanic BCS. The purpose of the current study is to describe the feasibility results of a 4-week pilot trial testing My Guide among Hispanic BCS. Twenty-five women enrolled in the study (75% recruitment rate) and 22 women were retained (91.6% retention rate). Mean time spent using My Guide across the 4 weeks was 9.25 hr, and mean score on the satisfaction survey was 65.91 (range 42-70), in which higher scores reflect greater satisfaction. Participants' scores on the Breast Cancer Knowledge Questionnaire significantly improved from study baseline (M = 9.50, SD = 2.92) to the postintervention assessment (M = 11.14, SD = 2.66), d = 0.59. Participants' HRQoL scores improved over the course of 4 weeks, but these improvements were not statistically significant. Overall, My Guide was feasible and acceptable. Future studies will assess the preliminary efficacy of My Guide in improving HRQoL in a larger, randomized trial of Hispanic BCS.
BECCA. [2019]Created by charity Breast Cancer Care, this app aims to help people with breast cancer adapt to life after hospital treatment ends.