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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital program called "With Love, Grandma" to help Hispanic breast cancer survivors and their adult daughters improve lifestyle habits, such as exercise and diet. Delivered through smartphones, the program includes educational content and activities over approximately 10-12 weeks. It suits Hispanic grandmothers who have completed treatment for certain cancers and reside in South Florida, along with their adult daughters who have young children. Participants should have a BMI of 25 or higher, indicating overweight, or engage in less than 150 minutes of exercise per week. As an unphased trial, this study provides a unique opportunity to contribute to innovative lifestyle interventions for cancer survivors and their families.

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 prior data suggests that this digital health program is safe for breast cancer survivors?

Research shows that the "With Love, Grandma" program is safe and easy to use. This online health program targets Hispanic women who have survived cancer and their adult daughters, aiming to improve habits like exercise and healthy eating. Studies have found that participants experience very few side effects. Many users find the program interesting and useful. No evidence of harmful effects exists, making it a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "With Love, Grandma" program because it offers a fresh, digital approach for supporting breast cancer survivors and their families, focusing on lifestyle changes and family dynamics. Unlike traditional treatments that may center on physical recovery and medical interventions, this program delivers educational and behavioral content directly to smartphones, making it accessible and convenient for users. By emphasizing family communication and parenting/grandparenting skills, the program aims to strengthen family bonds and provide emotional support, which are often overlooked in standard care options.

What evidence suggests that the "With Love, Grandma" digital program is effective for improving lifestyle behaviors in breast cancer survivors?

Research shows that "With Love, Grandma" is a promising online program aimed at improving lifestyle habits like exercise and diet. Early results suggest that this program helps Hispanic female cancer survivors and their families make healthier choices. In this trial, participants in the "With Love, Grandma" group will access eight lessons offering practical tips to enhance daily routines. Participants in past studies increased their physical activity and improved their eating habits, suggesting that the program may effectively support healthier lifestyles. ^{1 2 3 4 6}

Who Is on the Research Team?

Sara M St. George, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05721976

With Love, Grandma ("Con Cariño, Abuelita") Pilot Study 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 ...

2. withpower.com withpower.com/trial/phase-breast-neoplasms-4-2023-7d408

Digital Health Program for Breast Cancer Survivors Trial Overview 'With Love, Grandma' is a digital program aimed at improving lifestyle behaviors like physical activity and diet among Hispanic female cancer ...

3. news.med.miami.edu news.med.miami.edu/with-love-grandma/

With Love, Grandma - InventUM - University of Miami “Con Cariño, Abuelita” is designed for cancer survivors who are grandmothers and their adult daughters. It not only addresses the most directly influential ...

4. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/research/survivorship-research-at-sylvester/survivorship-research-studies

Survivorship Research Studies | Sylvester Comprehensive ... Con Carino Abuelita​​ The study focuses on developing and evaluating a web and mobile device-delivered (eHealth) intervention known as “Con Cariño, Abuelita” ( ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/results?cancer_type=breast&amp%3Bstudy_type=prevention_detection_risk&page=1

Research & Clinical Trials Search Results: Breast Cancer 3D Printed Breast Models in the Surgical Management of Breast Cancer. NCT05721976, With Love, Grandma ("Con Cariño, Abuelita") Pilot Study. NCT06966388, Study ...

6. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/impact-reports/2021/innovating-with-technology-and-teamwork/new-apps-for-cancer-survivors-and-families-promote-a-legacy-of-health

New Apps for Cancer Survivors and Families Promote a ... “Con Cariño, Abuelita” (“With love, Grandma”) is designed for cancer survivors who are grandmothers and mothers. The app not only addresses lifestyle behaviors ...