Digital Health Program for Breast Cancer Survivors

Overseen By Vanina Pavia, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami Sylvester Comprehensive Cancer Center

Disqualifiers: Metastatic cancer, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10-12 weeks

60 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{2 4 5 6 7}

How 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. ^{2 3 4 5 8}

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.

Research Team

Sara M St. George, PhD

Principal Investigator

University of Miami

Eligibility 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.

Owns a mobile device with internet access (e.g., smartphone, tablet)

I am a grandmother.

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.

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

Treatment Details

Interventions

• With Love, Grandma ("Con Cariño, Abuelita")

Trial Overview '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.

Participant Groups

Group I: With Love, Grandma ("Con Cariño, Abuelita") Group Experimental Treatment 1 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 Group Active Control 1 Intervention

This group is intended to reflect typical services cancer survivors and family members receive from healthcare providers.

Who Is Running the Clinical Trial?

University of Miami Sylvester Comprehensive Cancer Center

Lead Sponsor

Trials

11

Recruited

2,700+

The V Foundation for Cancer Research

Collaborator

Trials

21

Recruited

1,300+

Findings from Research

The pilot study involving 50 breast cancer survivors demonstrated that the e-health platform 'Healthy.me' was generally perceived as a useful resource for tailored health and lifestyle information, particularly in the first month of use.

However, user engagement declined significantly from 76% at one month to 48% at four months, primarily due to time constraints, limited content updates, and technical issues, indicating the need for ongoing improvements to enhance user retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An e-health strategy to facilitate care of breast cancer survivors: A pilot study. Tiong, SS., Koh, ES., Delaney, G., et al.[2022]

A multi-site, randomized controlled trial is investigating the effectiveness of a Smartphone application called My Guide, designed to improve health-related quality of life (HRQoL) and reduce cancer-specific distress among Hispanic breast cancer survivors over a six-week period.

The study will assess the impact of the intervention compared to a health education control app, with outcomes measured at three different time points, highlighting the potential of eHealth solutions to enhance supportive care accessibility for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors. Yanez, BR., Buitrago, D., Buscemi, J., et al.[2021]

The My Guide smartphone application significantly improved breast cancer knowledge among Latina breast cancer survivors, particularly for those who engaged with the app more frequently, compared to the attention-control group.

Participants using My Guide reported lower levels of self-blame than those using the My Health app, suggesting that culturally-informed interventions can promote better coping strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of smartphone interventions on cancer knowledge and coping among Latina breast cancer survivors: Secondary analysis of a pilot randomized controlled trial. Oswald, LB., Baik, SH., Buscemi, J., et al.[2023]

The study involved 80 Latina breast cancer survivors who used culturally informed smartphone applications (My Guide and My Health) for 6 weeks, showing high participant satisfaction (over 90%) and excellent retention rates (>90%).

Both applications led to temporary reductions in symptom burden and improvements in breast cancer well-being, indicating that technology can help engage Latina breast cancer survivors in their post-treatment care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. Yanez, B., Oswald, LB., Baik, SH., et al.[2021]

A study involving 80 Latina breast cancer survivors showed that participants used the My Guide and My Health apps for over 1 hour per week, indicating a strong interest in the content provided.

Clinically meaningful improvements in well-being were observed, particularly among low users of the My Guide app and high users of the My Health app, suggesting that even limited engagement with these eHealth interventions can positively impact health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Use of Smartphone-Based Interventions Among Latina Breast Cancer Survivors: Secondary Analysis of a Pilot Randomized Controlled Trial. Baik, SH., Oswald, LB., Buscemi, J., et al.[2021]

A significant 67% of breast cancer survivors expressed willingness to use eHealth technologies, like a connected electronic pillbox, to improve their adherence to adjuvant endocrine therapy (AET).

Younger survivors and those already using health applications or connected devices were more likely to accept these technologies, highlighting the importance of tailoring eHealth solutions to user profiles for better medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysing breast cancer survivors' acceptance profiles for using an electronic pillbox connected to a smartphone application using Seintinelles, a French community-based research tool. Goetzinger, C., Alleaume, C., Schritz, A., et al.[2022]

The My Guide smartphone application was found to be feasible and acceptable for use among Hispanic breast cancer survivors, with a high retention rate of 91.6% and an average usage time of 9.25 hours over 4 weeks.

Participants showed a significant increase in breast cancer knowledge after using the app, although improvements in health-related quality of life (HRQoL) were observed but not statistically significant, indicating potential for further research in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. Buscemi, J., Buitrago, D., Iacobelli, F., et al.[2021]

The app developed by Breast Cancer Care is designed to support individuals with breast cancer in adjusting to life after their hospital treatment has concluded.

This initiative highlights the importance of ongoing support and resources for breast cancer survivors to help them navigate their recovery and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BECCA. [2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

An e-health strategy to facilitate care of breast cancer survivors: A pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Study design and protocol for My Guide: An e-health intervention to improve patient-centered outcomes among Hispanic breast cancer survivors. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of smartphone interventions on cancer knowledge and coping among Latina breast cancer survivors: Secondary analysis of a pilot randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Brief culturally informed smartphone interventions decrease breast cancer symptom burden among Latina breast cancer survivors. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Patterns of Use of Smartphone-Based Interventions Among Latina Breast Cancer Survivors: Secondary Analysis of a Pilot Randomized Controlled Trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-based pilot intervention for Hispanic breast cancer survivors: a brief report. [2021]

8. England pubmed.ncbi.nlm.nih.gov

BECCA. [2019]